The Sr. Manager, Quality Systems -Audits & CAPAs is responsible for the day-to-day management and hands-on execution of CareTria’s internal audit, supplier audit, and Corrective and Preventive Action (CAPA) programs. This role manages the operational delivery of the full audit lifecycle including planning, scheduling, execution, reporting, and findings closure for internal, supplier, and third-party audits in alignment with cGMP, GDP, PDMA, and DSCSA requirements. The Sr. Manager leads the qualification, ongoing monitoring, and periodic reevaluation of service providers to ensure continued compliance with cGMP, GDP, QMS expectations, and client requirements.
Responsible to drive continuous improvement across the Quality Management System by ensuring audit outcomes and CAPA activities strengthen operational controls, mitigate risk, and support a constant state of inspection readiness for clients and regulatory authorities. This role ensures that all quality events including deviations, distribution errors, temperature excursions, and other nonconformances—are thoroughly investigated using sound root-cause methodologies and that effective, sustainable corrective and preventive actions are implemented and closed on time.
**Must reside within a commutable distance from our Lakewood, NJ location.
KEY RESPONSIBILITIES:
Oversee the day-to-day operational administrator of the eQMS, managing user access, workflow routing, training assignments, and system accuracy.
Execute and manage the annual Internal Audit Plan and Supplier/Third-Party Audit Plan under the direction of the department senior management, including scheduling, conducting audits, drafting comprehensive audit reports, and driving timely closure of all audit findings.
Develop and maintain audit questionnaires and checklists to standardize compliance assessments across all supplier and client interactions; recommend updates to the department senior management as regulations or program needs evolve.
Manage the Investigations and CAPA process in accordance with cGMP, GDP, PDMA, and DSCSA requirements, ensuring root cause analyses are thorough and that corrective/preventive actions are assigned, tracked, and closed within approved timelines.
Coordinate client-specific audit CAPAs and questionnaires, ensuring responses are professional, accurate, and submitted within contractual timelines; escalate complex or high-risk client quality matters to the Associate Director. Partner with the Quality Control organization on shared quality events and investigations.
Manage the lifecycle of QMS events, including deviations, change controls, and non-conformances, ensuring they are documented, investigated, and mitigated per approved SOPs and within required timeframes.
PEOPLE MANAGEMENT & TEAM LEADERSHIP:
Directly manage, mentor, and develop QA staff within the Audits & CAPAs team, establishing clear performance goals and supporting professional development in audit and investigation competencies.
Manage daily activities and workloads of QA staff to ensure all audit schedules, investigation timelines, corrective action plans, and compliance deadlines are met; escalate resource conflicts or program risks to the Associate Director.
Conduct regular performance check-ins and formal evaluations; provide ongoing coaching and technical guidance to ensure staff proficiency in audit execution, root cause analysis, and CAPA writing.
Track, trend, and compile Quality KPIs (e.g., CAPA cycle time, audit findings closure rate, overdue investigations) and prepare reporting packages for presentation to Senior Leadership at Management Review Meetings.
Monitor team workflows daily to ensure no investigation or CAPA reaches “Overdue” status without a pre-approved extension and documented impact assessment; escalate imminent overdue items to department senior management in advance.
The above duties are meant to be representative of the position and not all-inclusive.
MINIMUM JOB REQUIREMENTS:
Education: Bachelor’s degree in Life Sciences, Supply Chain Management, or a related technical field.
Experience: Minimum of 4–6 years in Quality Assurance within the pharmaceutical or 3PL industry, with at least 2 years specifically focused on Audits, CAPA, and Investigations.
Professional Certification: ASQ Certified Quality Auditor (CQA), RAPS RAC, or equivalent quality/compliance certification is desirable.
KNOWLEDGE, SKILLS & ABILITIES:
Demonstrated ability to author clear, concise, and defensible investigation reports and CAPA responses suitable for regulatory and client review.
Experience using enterprise eQMS platforms (e.g., MasterControl, TrackWise, Veeva).
Ability to evaluate analytical and technical quality data to identify, track, and resolve unfavorable quality trends; strong working knowledge of cGMP, GDP, PDMA, DSCSA, and applicable FDA regulations governing pharmaceutical distribution.
PHYSICAL DEMANDS:
Ability to sit, stand, and work at a computer for extended periods.
Location of job activities 100% inside
Extensive manual dexterity (keyboarding, mouse, phone)
Expected to support Audits remotely or physically present at facility as needed.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The expected base pay range for this position is $90,000-$110,000 per year. The actual compensation for the position may vary based on market differences and on factors such as skills, experience, qualifications and can vary based on location and/or work schedule. In addition to base pay, CareTria offers a comprehensive benefits package. Full-Time benefits include access to health, dental, and vision insurance; retirement plan options; paid time off; paid parental leave; employee assistance programs; and other perks. Eligible employees may also have access to performance bonuses.
CareTria is an Equal Opportunity Employer
