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

Sr Manager, Quality Assurance

$120k - $145k

Breckenridge Pharmaceutical Inc

Job Description

Job Description

About the Company

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

About the Role

This position reports to the Vice President, Quality Assurance and will manage or support: cGMP compliance assessment of contract manufacturers, the company SOP and Training systems, QA/QC Testing /Audit program, and Quality/Compliance decisions related to the Company’s ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements, Medical Foods or Foods for special dietary use.

Responsibilities

  • Perform, support and evaluate third party audits of current and proposed vendors for cGMP compliance
  • Manage the SOP system, including writing/ revising and maintaining SOPs, SOP Tracking and SOP Training
  • Support market distribution of batches
  • Manage the review and resolve batch deviations / Out-of-Specification (OOS) reports and proposed Corrective and Preventative Actions (CAPAs) from manufacturers for Dietary Supplements and Medical Foods
  • Manage product quality complaints
  • Support FDA audits/inspections of the company or its manufacturing partners, as needed
  • Product Quality Reviews, including review of manufacturers' reports of annual product reviews
  • Manage change control review of Dietary Supplements and Medical Foods products
  • Batch record reviews, as required

Qualifications

  • Bachelor of Science required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)
  • Minimum 10 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems (preferably at least 5 years in a QA-management role)
  • Ability to travel domestically 3-4 times per year to perform audits on facilities, potential international travel

Required Skills

  • Strong knowledge of quality and compliance for drug production
  • Strong knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111)
  • Strong leadership skills
  • Excellent attention to detail and organizational skills
  • Effective communication and interpersonal skills

Pay range and compensation package

At Breckenridge Pharmaceutical Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

  • Flexible approach to how we work
  • Health benefits and time-off programs
  • Competitive compensation packages
  • The anticipated annual salary for this role is $120,000 – 145,000

Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Vacancy posted 19 days ago
Similar jobs that could be interesting for youBased on the Sr Manager, Quality Assurance in Berkeley Heights, NJ vacancy
  • $150k - $190k

     ...Manager/Sr. Manager Clinical Quality Assurance - CQA Salary: $150–190k (flexible depending on experience) Location: Morristown, NJ area – Hybrid Preferred - Remote is possible Therapeutic Area : Oncology and Rare Disease We are partnered with a growing,... 
    Senior
    For contractors
    Remote work
    Flexible hours

    Scientific Search

    Morristown, NJ
    4 days ago
  •  ...Job Title: Senior Manager, Medical & Affiliates, R&D Quality Location: Parsippany, NJ 07054 (Hybrid) Duration...  ...cure unmet medical needs? Seeking a Sr. Manager/Associate Director of...  ...an accountable complaint culture Assure completeness and currency of documentation... 
    Senior
    Flexible hours

    Spectraforce Technologies

    Avenel, NJ
    3 days ago
  • $92.96k - $139.44k

     ...community of brilliant and diverse minds to make a real difference, there's only one choice. Senior Process and Compliance Manager-Trait Quality Position Overview: As a key player in our Plant Biotechnology team, you are responsible for assisting with the... 
    Senior
    Local area

    Bayer

    Whippany, NJ
    1 day ago
  • Closets By Design NW New Jersey is seeking a hands-on leader to manage daily operations in Chatham. The successful candidate will oversee plant operations, manage employees, and schedule production to meet deadlines. Strong supervisory experience, particularly in woodworking... 
    Suggested

    Closets By Design NW New Jersey

    Chatham, NJ
    3 days ago
  • A leading personal care manufacturer is seeking a Quality Control (QC) Manager to lead quality control operations. This role focuses on ensuring compliance with quality standards, supervising QC lab functions, and managing a team. Ideal candidates will have over 5 years... 
    Senior

    Atrium

    Woodbridge, NJ
    1 day ago
  • $116.4k - $174.6k

    Job Title: Manager, Medical Affairs Quality, RD PV QA Job Summary The Manager, Medical Affairs Quality will provide operational leadership and direction...  ...assigned programs and, in close collaboration with the Sr. Director, Medical Affairs QA, ensure implementation of the... 
    Local area

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    2 days ago
  • $93.76k - $168.77k

    Anticipated End Date: 2026-06-30 Position Title: Business Change Manager Sr. / Sr. Test Lead Job Description: Business Change Manager Sr. /...  ...components. Defines appropriate testing methods to employ to assure developed products conform to requirements and design. Conduct... 
    Senior
    Full time
    Contract work
    Temporary work
    Work experience placement
    Work at office
    Local area
    Monday to Friday
    Day shift
    2 days per week
    1 day per week

    Elevance Health

    Iselin, NJ
    8 hours ago
  •  ...patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to... 
    Full time
    Temporary work
    Remote work

    PerkinElmer

    Kenilworth, NJ
    17 hours ago
  • $90k - $120k

     ...on-site) Scope The Product Surveillance Sr. Supervisor is responsible for providing...  ...and has accountability for investigation quality, prioritization, escalation decisions, and...  ...of post‑market surveillance and Quality Management System processes based on investigation outcomes... 
    Senior
    Contract work
    Work at office

    CooperSurgical

    Livingston, NJ
    4 days ago
  •  ...high standards it imposes on all the participants in the value chain. Quality standards are driven by the Original Equipment Manufacturers and are usually governed by the ISO/TS 16949 Quality Management System. The Manager Global Quality Governance will be responsible... 
    Local area

    Direct Staffing Inc

    Woodbridge, NJ
    3 days ago
  •  ...in SAP testing, with a focus on S/4HANA implementations. The role involves developing test strategies, leading testing teams, and managing defect tracking. Strong knowledge of SAP modules and experience with tools like HP ALM and Jira are essential. The position demands... 
    Senior

    Ztek Consulting

    Basking Ridge, NJ
    1 day ago
  •  ...days of contract award). Responsibilities: Oversee all quality assurance functions within assigned task areas. Lead and supervise...  ...Expertise: Demonstrated expertise in quality control operations management. Ability to develop, update, and monitor internal... 
    Contract work
    Temporary work
    Remote work
    Flexible hours

    Telesolv Consulting

    Summit, NJ
    2 days ago
  • $110.5k - $156k

    Sr. Fragrance & Flavor Evaluator Location: North America, United States, New Jersey, Summit Work Location: Hybrid Responsibilities...  ...allocation is consistent with overall business objectives - manages projects throughout the fragrance/flavor development cycle for all... 
    Senior
    Shift work

    Kenvue

    Summit, NJ
    17 hours ago
  •  ...testing for ADP's cloud-based solutions. This role demands proactive leadership, continuous learning, and collaboration to ensure quality results. The ideal candidate holds a Bachelor's degree in a related field and has at least six years of experience, with specific skills... 
    Senior

    ADP, Inc.

    Roseland, NJ
    4 days ago
  •  ...Eligibility:US Permanent Eligibility to Work Required Key Technology:SDET, BDD Job Responsibilities: Manage and coach 4 direct reports and 36 indirect reports. Drive Quality Practices and Standards across the Organization Champion the culture of quality delivery through... 
    Permanent employment
    Local area
    Relocation

    Highbrow LLC

    Berkeley Heights, NJ
    1 day ago
  • A leading healthcare organization in New Jersey is seeking a Clinical Nurse Manager to oversee clinical operations across various perioperative areas. The role includes managing nursing services, ensuring compliance with regulations, and supporting staff development. Ideal... 

    Summit Health Management

    Berkeley Heights, NJ
    1 day ago
  • $48k - $84.5k

     ...Department to ensure compliance with safety and regulatory standards. Responsibilities include administration, quality control, communication, and team management to foster high-quality clinical outcomes. The ideal candidate will have a doctoral degree in clinical... 
    Full time

    Asct

    Summit, NJ
    2 days ago
  • $70k - $80k

    IQVIA LLC is seeking a Quality Assurance Business Analyst Supervisor to lead quality monitoring in New Providence, New Jersey. This role involves overseeing quality assurance activities, ensuring compliance, and driving continuous improvement across patient access programs... 

    IQVIA LLC

    New Providence, NJ
    17 hours ago
  • $100k - $165.6k

    Shoptalk is looking for a Senior Quality Assurance and Test Automation Engineer in Berkeley Heights, New Jersey. The ideal candidate will have over 8 years of experience in quality assurance and test automation, specifically in enterprise-scale platforms. Responsibilities... 
    Senior

    Shoptalk

    Berkeley Heights, NJ
    4 days ago
  • An established industry player is seeking a meticulous Quality Assurance Label Specialist to support critical document control operations....  ...role involves ensuring compliance with cGMP regulations and managing the issuance of production labels. You will work collaboratively... 

    TechDigital Group

    Summit, NJ
    17 hours ago
  • A leading pharmaceutical company located in Florham Park, NJ, seeks a QA Product Manager. This role requires ensuring the quality and compliance of pharmaceutical products through collaboration with cross-functional teams. The ideal candidate will have a Bachelor's degree... 

    Shionogi Inc.

    Florham Park, NJ
    17 hours ago
  • $110.5k - $156k

    Kenvue is seeking a Senior Fragrance & Flavor Evaluator to guide the fragrance/flavor development process, liaise between teams, and ensure compliance with project requirements. This role requires a minimum of 10 years in F/F development, an acute sense of smell, and skills...
    Senior

    Kenvue

    Summit, NJ
    17 hours ago
  • $173.2k - $272.6k

     ...of New Modalities Manufacturing Division Quality, this leader is responsible for...  ...implementation of a fit‑for‑purpose quality management system and ensure strategic quality oversight...  ...products. Experience in both Quality Assurance and Quality Control. Experienced in interacting... 
    For contractors
    Worldwide

    Merck Sharp & Dohme

    Rahway, NJ
    2 days ago
  • A technology company is seeking a QA Engineer with over 9 years of experience to develop and execute test plans for quality assurance. The ideal candidate will have extensive knowledge of testing tools, Agile methodologies, and hands-on experience with automation testing... 
    Senior

    Highbrow LLC

    Berkeley Heights, NJ
    17 hours ago
  • A technology company is seeking a QA Engineer with over 9 years of experience to develop and execute quality assurance test plans. The role involves leading test planning, overseeing test case development, and collaborating with technical teams to ensure software quality... 
    Senior

    Highbrow LLC

    Berkeley Heights, NJ
    4 days ago
  •  ...Supervisor, Point of Care Testing in Summit, NJ. This role involves ensuring quality patient testing, overseeing specimen processing, and technical operations. The successful candidate will lead team management, communicate effectively across departments, and ensure compliance... 

    Atlantic Health System

    Summit, NJ
    1 day ago
  • $68.33k - $116.13k

     ...Job Description Job Description The Quality Assurance Supervisor leads quality and process improvement within manufacturing operations...  ...Preferred Qualifications: • 5+ years of experience with quality management systems (e.g., ISO 9001). • 3+ years of experience with... 

    Hosokawa Micron International

    Summit, NJ
    a month ago
  •  ...with cGMP regulations at the cell therapy manufacturing facility. Responsibilities include managing QA transformation programs and serving as a primary authority for quality assurance during audits. The ideal candidate must have a Bachelor's in Science or Engineering and... 
    Flexible hours

    Scorpion Therapeutics

    Summit, NJ
    1 day ago
  • $104k - $156k

    Position Summary Manager II, Quality Engineer - Supply Chain - responsible for leading continuous improvement initiatives in a Walmart Distribution Center, driving quality excellence, and ensuring compliance with company policies and standards of ethics. What You’ll Do... 
    Temporary work
    Work at office

    Feitong Buke

    Irvington, NJ
    1 day ago
  • Owen Health Care Inc. is seeking an Operations Manager in Vauxhall, New Jersey. The ideal candidate will be a Licensed Clinical Social...  ...supervising cases, ensuring organizational compliance, and leading quality improvement initiatives. The position offers a competitive... 

    Energy Jobline ZR

    Millburn, NJ
    17 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Sr Manager, Quality Assurance. Be the first to apply!