Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Associate Director, Clinical QA

$150k - $190k
Full-time

Systimmune

This position requires a hybrid working model, with expectations of being in office 2-3 days a week at an office in Princeton, New Jersey (preferred location).

Company Overview:

SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered in Redmond, WA. Our mission is to revolutionize cancer treatment by developing breakthrough-therapeutic multi-specific antibodies and ADCs. With eight assets in ongoing clinical trials and a robust preclinical pipeline, we are committed to advancing innovative therapies from discovery through IND-enabling stages.

Job Summary:

The Associate Director, Clinical Quality Assurance (GCP/GVP) is responsible for providing strategic leadership and oversight of Clinical Quality programs to ensure compliance with global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations, guidelines, and company standards.

This position partners closely with Clinical Operations, Drug Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, and external vendors to ensure the effective implementation of quality systems, proactive risk management, inspection readiness, and continuous improvement initiatives. The Associate Director serves as a key quality advisor across development programs and contributes to the advancement of a culture of quality and compliance throughout the organization.

Quality Systems & Compliance
  • Provide oversight and guidance to ensure compliance with global GCP and GVP regulations, including FDA, EMA, MHRA, PMDA, NMPA, and ICH requirements.
  • Support the development, implementation, and continuous improvement of the Clinical Quality Management System (QMS).
  • Lead quality risk management activities, including quality risk assessments and mitigation planning.
  • Ensure quality processes remain aligned with evolving regulatory expectations and industry best practices.
Audit Program Management
  • Develop and execute risk-based annual GCP/GVP audit programs.
  • Lead and/or oversee internal, external, investigator site, vendor, CRO, and pharmacovigilance audits.
  • Review audit findings, assess systemic impact, and ensure appropriate remediation activities are implemented.
  • Identify compliance trends and recommend strategic quality improvements.
Inspection Readiness
  • Lead inspection readiness activities across clinical development and pharmacovigilance functions.
  • Support regulatory agency inspections and sponsor audits.
  • Coordinate inspection preparation activities, including mock inspections and readiness assessments
  • Provide strategic guidance during regulatory inspections and ensure effective management of inspection responses.

CAPA & Quality Event Management

  • Oversee investigations involving deviations, non-compliance events, inspection observations, and audit findings.
  • Facilitate root cause analysis and ensure CAPAs are appropriately developed, implemented, and verified for effectiveness.
  • Monitor quality events and CAPA metrics to identify trends and opportunities for improvement.
    Vendor Quality Oversight
  • Lead quality oversight activities for CROs, pharmacovigilance vendors, laboratories, technology providers, and other GCP/GVP service providers.
  • Support vendor qualification, risk assessments, audits, and ongoing performance monitoring.
  • Provide quality input during vendor selection and governance activities.
  • Ensure outsourced activities maintain appropriate regulatory compliance and quality standards.
  • Quality Metrics & Risk-Based Quality Management
  • Establish and monitor key quality metrics and compliance indicators.
  • Analyze quality data to identify emerging risks, compliance trends, and systemic improvement opportunities.
  • Support implementation of Risk-Based Quality Management (RBQM) strategies and Quality Tolerance Limits (QTLs).
  • Present quality metrics and compliance status to senior leadership.

SOP Development & Training

  • Lead development, review, and lifecycle management of GCP, GVP, and Clinical Quality SOPs and associated procedures.
  • Develop and deliver quality training programs.
  • Provide quality consultation and mentoring to cross-functional teams.
  • Promote a culture of quality, inspection readiness, and continuous improvement.

Leadership & Strategic Partnership

  • Serve as a trusted quality advisor to clinical development teams.
  • Lead cross-functional quality initiatives supporting organizational objectives.
  • Mentor junior quality professionals and support development of departmental capabilities.
  • Contribute to long-term Clinical Quality strategy, resource planning, and operational excellence initiatives.

Qualifications/Requirements: 

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field required.
  • 8+ years of experience in Clinical Quality Assurance, Clinical Research, Pharmacovigilance, or related pharmaceutical/biotechnology functions.
  • Minimum 5 years of direct GCP Quality Assurance experience.
  • Demonstrated experience leading GCP audits, vendor audits, and inspection readiness programs.
  • Experience supporting regulatory authority inspections (FDA, EMA, MHRA, PMDA, NMPA, or equivalent).
  • Experience within oncology clinical development strongly preferred.
  • Experience working in global clinical development environments and managing outsourced service providers.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional development and career advancement.
  • Work in a dynamic and collaborative environment at the forefront of clinical research.
  • Contribute to meaningful projects that have the potential to improve patient outcomes and advance medical science.

The hiring pay range for this position is $150,000 - $190,000 per year based on skills, education, and experience relevant to the role.

SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

Vacancy posted 15 days ago
Similar jobs that could be interesting for youBased on the Associate Director, Clinical QA in Princeton, NJ vacancy
  • $209.25k - $253.57k

     ...Associate Director, Clinical PharmacologyWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in... 
    Suggested
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Work at office
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb Company

    Princeton, NJ
    1 day ago
  • $150k - $200k

     ...Weare seeking a high-quality Senior Manager/Associate Director of Clinical Pharmacology to lead the development and execution of clinical pharmacology strategies for ADC assets. The ideal candidate will provide expertise in pharmacokinetics, dose optimization, pharmacometrics... 
    Suggested
    Full time

    Systimmune

    Princeton, NJ
    24 days ago
  • $156k - $234k

     ...Genmab is seeking an experienced Associate Director for their PV QA team based in Plainsboro Township, NJ. The role involves leading quality audits and inspections, mentoring colleagues, and developing audit strategies. Candidates should hold an MSc in Natural Science... 
    Suggested

    Genmab

    Plainsboro, NJ
    4 days ago
  • $186.49k - $278.88k

     ...Associate Director, Global Medical ReviewThe Associate Director, Global Medical Review provides input into the medical review of safety data...  ...Safety Product Leaders, PV Operations, Regulatory Affairs, Clinical Development, Quality, affiliates, and vendors to support patient... 
    Suggested
    Temporary work
    Local area
    Flexible hours

    Avanir Pharmaceuticals

    Princeton, NJ
    4 days ago
  • $164.5k - $201k

     .... Job Summary Sun Pharma is seeking a strategic and dynamic Associate Director, Marketing (DTC & HCP) – Medical Dermatology to serve as a key...  .... Provide strategic direction for initiatives that drive clinical understanding, brand awareness, and prescribing behavior. Partner... 
    Suggested
    Work at office
    Flexible hours

    DaMar Staffing

    Princeton, NJ
    1 day ago
  • $165k - $220k

     ...Associate Medical Review Director Facility: Reg Affairs & Safety Pharmacovigilance Location: Plainsboro, NJ, US About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within... 
    Local area
    Flexible hours
    Night shift

    Novo Nordisk USA

    Plainsboro, NJ
    2 days ago
  • $240k - $255k

     ...Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and activities...  .../label. Cross-check everything against the underlying clinical data, literature, abstracts/manuscripts and ensure that... 
    Temporary work
    Work experience placement
    Flexible hours

    Ascendis Pharma

    Princeton, NJ
    21 days ago
  • $156k - $234k

     ...fit? Then we would love to have you join us!The role R&D QA is looking for an Associate Director to the PV QA team that is an experienced auditor within...  ...target stakeholders such as GDS&PV, Medical Affairs, Clinical Operations and Commercial. In 2025 Genmab became MAH in... 
    Full time
    Fixed term contract
    Work at office
    Remote work

    Genmab

    Princeton, NJ
    2 days ago
  • $157.36k - $236.04k

     ...lot of fun while doing so.Does this inspire you and feel like a fit? Then we would love to have you join us! Position: Associate Director, Clinical Data ManagementDepartment: Clinical Data Integration and ReportingReports to: Director of DM, Team Lead, Clinical Data ManagementOverviewAn... 
    Full time
    Fixed term contract
    Local area

    Genmab

    Princeton, NJ
    4 days ago
  •  ...quality medical communications programs. Associate Medical Direct - Publications About...  ...programs. About The Role The Associate Medical Director (“AMD”) will assist senior scientific...  ...assigned medical communications are accurate, clinically relevant and reflect the most recent... 
    Freelance
    Flexible hours

    Ashfield MedComms, an Inizio Company

    Yardley, PA
    4 days ago
  • $110k - $140k

     ...Precision AQ, based in Yardley, PA, is seeking an Associate Scientific Director to lead strategic medical communications. In this role, you'll be essential in guiding medical writers and ensuring high-quality deliverables that align with client objectives. The ideal candidate... 

    Precision AQ

    Yardley, PA
    4 days ago
  •  ...Statewide Associate Medical Director UCHC Administration University Correctional Health Care (UCHC), operating within Rutgers, The State University...  ...Job Category - Staff & Executive - Medical (Clinical) - Physician Department - UCHC Administration Posting... 
    Full time
    Flexible hours
    Shift work

    Rutgers University

    Trenton, NJ
    14 hours ago
  • $155k - $193.2k

     ...three days per week on average. Position Summary The Associate Director will be responsible for the oversight of Translational...  ...field Targeting 6-8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within... 
    Work at office
    Local area
    Remote work
    Night shift
    3 days per week

    ACADIA Pharmaceuticals

    Princeton, NJ
    3 days ago
  • $186.5k - $207k

     ...Sun Pharma is seeking an experienced and motivated Associate Director of Biostatistics to join our rapidly growing organization. Reporting...  ...execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions. This person will... 
    Flexible hours

    Sun Pharmaceutical Industries

    Princeton, NJ
    4 days ago
  • $190k - $200k

     ...can join our dynamic Global Scientific Training team as an Associate Director! In this pivotal role, you will have the opportunity to shape...  ...industry required ~ Prior Biotech/Pharma Field Medical or Clinical experience, required ~ PharmD/PhD with training experience... 
    Temporary work
    Work at office
    Flexible hours

    Ascendis Pharma

    Princeton, NJ
    11 days ago
  • $100k - $180k

     ...leading global biologics technology platform is seeking an Associate Director for Quality Assurance in Cranbury, NJ. This role focuses on...  ...establishing and improving Quality Management Systems supporting GMP clinical manufacturing. Successful candidates will have extensive... 

    Confidential

    Cranbury, NJ
    4 days ago
  • $152.7k - $267.3k

     ...Are you ready to experiment with us?   The Position The Associate Director, Paid and Earned Media is responsible for paid and earned...  ...the pharmaceutical industry, including Medical, Regulatory, clinical processes and market dynamics ~ Patient tactical experience... 
    Contract work
    Fixed term contract
    Interim role
    Local area
    Flexible hours
    Night shift

    Novo Nordisk

    Plainsboro, NJ
    2 days ago
  • $240k - $300k

     ...an office in Princeton, New Jersey (preferred location) or Redmond, Washington. Company Overview: SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered in Redmond, WA. Our mission is to revolutionize cancer treatment by developing... 
    Full time
    Contract work
    Work at office
    2 days per week
    3 days per week

    Systimmune

    Princeton, NJ
    23 days ago
  • $145.6k - $279.4k

     ...Job Description Summary The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and execution for...  ...Provide regulatory leadership and guidance in partnership with Clinical, Nonclinical, CMC, Analytical Development, Quality,... 
    Work at office
    Visa sponsorship
    Work visa
    Relocation package

    U023 (FCRS = US023) Sandoz Inc

    Princeton, NJ
    3 days ago
  •  ...help support individual and team success.We have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director or Director, Clinical Operations. Title and level commensurate with experience. The Associate Director/Director, Clinical Operations is... 
    Full time
    Contract work
    Work at office
    Local area
    Immediate start

    Tris Pharma

    Monmouth Junction, NJ
    2 days ago
  • $152.7k - $267.3k

     ...The Position At Novo Nordisk, we are navigating one of the most dynamic and consequential trade environments in decades. As Associate Director, Trade & Tariffs, you will have the unique opportunity to help shape the enterprise's response to evolving U.S. trade, tariff... 
    Work at office
    Local area
    Worldwide
    Flexible hours
    Night shift

    Novo Nordisk

    Plainsboro, NJ
    a month ago
  • $189.2k - $283.8k

     ...is preferred. We expect at least 15 years of experience in clinical research or clinical data management. We require a minimum of...  ...building a workplace where authentic contributions are valued. This Director role sits within our External Data Management leadership... 
    Full time

    Genmab

    Princeton, NJ
    11 days ago
  • $152k - $210k

     ...of driving value through human-centered design pull you in? Are you ready to experiment with us?   T he Position The Associate Director of NovoCare Mobile Business Owner is responsible for shaping and growing the NovoCare mobile experience as a core consumer engagement... 
    Local area
    Flexible hours
    Night shift

    Novo Nordisk

    Plainsboro, NJ
    9 days ago
  •  ...Princeton Junction, NJ 08550 Date Posted: 09/01/2026 Category: Center Based Education: Bachelors Degree Title: Practice Manager / Clinic Director Location: Princton Junction, NJ Join an established - and growing - organization as Kaleidoscope ABA looks for its newest... 
    Weekly pay
    Full time
    Contract work
    Temporary work
    Work experience placement
    Work at office

    Kaleidoscope ABA Therapy Services

    Princeton, NJ
    3 days ago
  •  ...Title: Practice Manager / Clinic Director Location: Princeton Junction, NJ Join an established - and growing - organization as Kaleidoscope ABA looks for its newest addition to the team as an Operations Manager. The Practice Manager / Clinic Director position is an integral... 
    Weekly pay
    Full time
    Work experience placement
    Work at office

    Delta-T Group North Jersey, Inc.

    West Windsor, NJ
    3 days ago
  •  ...Practice Manager / Clinic Director Location: Princeton Junction, NJ 08550 Date Posted: 09/01/2026 Category: Center Based Education: Bachelors Degree Title: Practice Manager / Clinic Director Location: Princton Junction, NJ Join an established... 
    Weekly pay
    Full time
    Contract work
    Temporary work
    Work experience placement
    Work at office

    Kaleidoscope ABA Therapy Services

    Princeton Junction, NJ
    3 days ago
  • $150.03k - $224.25k

     ...The Associate Director, R&D Strategic Sourcing, will lead strategic sourcing efforts for key R&D categories. This role plays a critical part in enabling innovation by securing high-performing suppliers and ensuring alignment between scientific objectives and sourcing... 
    Full time
    Contract work
    Temporary work
    Local area
    Flexible hours

    Otsuka Pharmaceutical Co., Ltd.

    Princeton, NJ
    a month ago
  • $200k - $300k

    SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located...  ...level for this role could range across Director/Sr. Director/Exec Director based on the...  ...the preparation for Agency meetings and associated briefing document preparation Lead and... 
    Full time

    Systimmune

    Princeton, NJ
    8 days ago
  • $145k - $160k

     ...Associate Director, Biostatistics Position: Associate Director, Biostatistics Salary Range: $145K-$160K Location: Sommerset, NJ (...  ...supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in... 
    Contract work
    Temporary work
    Remote work
    Worldwide
    Flexible hours

    Pharmaron

    Somerset, NJ
    3 days ago
  • $100k - $115k

     ...Overview Join us as an Associate Scientific Director on our Enterprise Content team and help shape educational experiences that make a real difference...  .... Analyze and apply evidence-based medical literature, clinical practice guidelines, and disease-state knowledge across... 
    Temporary work

    MSS MJH Shared Services

    Cranbury, NJ
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director, Clinical QA. Be the first to apply!