Quality Systems Specialist III

Job Description

Job Description

Job Title: Quality Systems Specialist III- *Hybrid, onsite in Parsippany, NJ OR Foster City, CA*

Job Description

The Quality Systems Specialist III serves as the Quality Site Lead for assigned contract organizations, providing risk-based quality oversight across development, technology transfer, validation, launch, and commercial supply. This role implements external quality plans, monitors compliance with regulatory and internal standards, and ensures robust quality governance for outsourced manufacturing and testing activities. The position works cross-functionally with internal and external partners to maintain product quality, regulatory compliance, and continuity of supply in a dynamic, GMP-regulated environment.

Responsibilities

• Serve as the Quality Site Lead for assigned external manufacturing and testing organizations, with guidance from senior quality leadership.
• Provide routine, risk-based quality oversight across development, technology transfer, validation, launch, and commercial supply activities.
• Implement the external quality plan for assigned sites in alignment with product, network, regulatory, and supply objectives.
• Monitor contract organizations compliance with internal standards, regulatory requirements, and Quality Agreements, and escalate significant gaps in a timely manner.
• Represent Quality on Product Quality Teams and cross-functional CMC, development, commercialization, supply, and governance teams.
• Build and maintain productive working relationships with external Quality counterparts, ensuring clear communication, governance, and accountability.
• Participate in quality governance forums and business reviews, using metrics, trends, audit outcomes, and operational performance data to identify and drive corrective actions.
• Coordinate the development, implementation, and maintenance of Quality Agreements covering manufacturing, testing, disposition, change control, investigations, validation, data governance, communication, and regulatory support.
• Oversee timely management and closure of deviations, investigations, CAPAs, change controls, complaints, validation activities, and other quality events at assigned sites.
• Support batch record review, release, and disposition activities, and facilitate resolution of issues that may affect product quality, patient safety, regulatory compliance, or supply continuity.
• Track the performance of contract organizations using defined metrics and coordinate remediation or capability-building actions when expectations are not met.
• Partner with Manufacturing, Supply Chain, Development, Quality Control, Regulatory CMC, Auditing, and Quality Systems teams to implement quality and regulatory requirements and support the production plan.
• Support quality issue escalations and risk assessments involving potential product impact, batch disposition decisions, regulatory reporting, or continuity of supply.
• Apply Quality Risk Management principles to identify, document, mitigate, and escalate compliance, product, and supply risks associated with external operations.
• Maintain inspection readiness, including PAI/PLI readiness, for assigned sites and support regulatory inspections, responses, commitments, and remediation activities.
• Review audit and inspection findings, monitor CAPA completion and effectiveness, and support the generation and maintenance of compliant GMP documentation.
• Stay current with relevant regulatory expectations and industry standards and help translate changes into site oversight practices and quality system improvements.
• Contribute to continuous improvement of external quality systems, governance structures, metrics, processes, and training related to outsourced operations.
• Provide work direction, coaching, and project leadership to Quality professionals as needed, without direct people-management responsibility.
• Review records and documents, including change controls and deviations, ensuring accuracy, completeness, and compliance with GMP requirements.
• Support multiple clinical contract manufacturing organizations, including those based in China, with a focus on manufacturing-related quality oversight.
• Leverage expertise in biologics, parenterals, aseptic operations, or drug product filling to provide effective oversight of relevant manufacturing processes.
• Demonstrate flexibility in managing changing priorities with a strong sense of urgency, particularly in support of clinical and commercial supply needs.

Essential Skills

• 5+ years of relevant experience and a bachelors degree in science or a related field, or 4+ years of relevant experience and an advanced science or business degree.
• Relevant experience in Quality Assurance, Quality Control, manufacturing, validation, or another GMP-regulated function within the biopharmaceutical or pharmaceutical industry.
• Working knowledge of GMP manufacturing processes, including testing, packaging, labeling, validation, product lifecycle management, batch documentation, or outsourced operations.
• Demonstrated ability to provide quality oversight of contract manufacturing or testing organizations, or strong readiness to do so.
• Experience with key quality system elements such as validation, shop-floor quality support, batch record review, deviation management, CAPA management, and inspection readiness.
• Working experience in parenteral, aseptic, and/or biologics operations, particularly in a manufacturing or quality oversight capacity.
• Ability to review and assess change controls and deviations, with the capability to author such documentation when required.
• Strong understanding and practical application of Quality Risk Management principles in a GMP environment.
• Proficiency in interpreting and applying regulatory requirements and internal quality standards to external operations.
• Ability to analyze metrics, trends, and audit outcomes and translate them into meaningful quality and performance improvements.
• Strong communication skills to effectively collaborate with internal stakeholders and external quality counterparts.
• Demonstrated ability to manage multiple priorities and adapt to changing demands with a sense of urgency.

Additional Skills & Qualifications

• Advanced degree in a scientific or business discipline is preferred when combined with relevant industry experience.
• Experience supporting contract manufacturing or testing operations is preferred, particularly for clinical or commercial supply.
• Exposure to validation activities, including process validation, cleaning validation, or equipment qualification, within GMP environments.
• Experience in shop-floor quality support, including real-time decision-making and issue resolution in manufacturing areas.
• Background in inspection readiness activities, including preparation for regulatory inspections and support during and after inspections.
• Experience with biologics, parenteral products, aseptic processing, and drug product filling operations.
• Ability to provide coaching, guidance, or project leadership to other Quality professionals without direct line management responsibilities.
• Comfort working with global contract manufacturing organizations, including those located in China, and navigating cross-cultural collaboration.
• Strong organizational skills and attention to detail in reviewing records, documents, and quality system data.
• Capability to work effectively in cross-functional CMC, development, commercialization, and supply teams.

Work Environment

This hybrid role is based in either South San Francisco, CA or Parsippany, NJ, combining on-site work with remote flexibility as business needs require. The position operates within a GMP-regulated biopharmaceutical environment focused on manufacturing-related activities and oversight of multiple clinical contract manufacturing organizations, including sites in China. The work involves frequent interaction with cross-functional teams and external partners, extensive review of GMP records and documentation, and participation in quality governance forums and business reviews. The environment emphasizes inspection readiness, data integrity, and adherence to established quality systems and regulatory expectations, while requiring adaptability to changing priorities and timelines.

This is a Contract position based out of Foster City, CA.

The pay range for this position is $58.00 - $65.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Foster City, CA.

This position is anticipated to close on Nov 18, 2026.

This is a hybrid position in Foster City,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.