Senior Quality Manager (Contract)
About The Position
The Senior Quality Manager is an advanced technical resource in quality assurance and compliance, providing end-to-end QA oversight of contract analytical laboratories supporting clinical and commercial biologics and combination product programs. The role takes ownership of vendor meetings with analytical laboratories to enhance oversight of vendor performance, drive timely investigation closure, and ensure alignment with Vertex’s quality and compliance standards. The position is a six-month contract with the possibility of an extension. It is a temporary role through a third-party agency partner, with the selected individual employed by that agency and assigned to Vertex Pharmaceuticals. The pay range is $75–$85 per hour, with overtime eligibility in accordance with federal and state requirements.
Requirements
- Bachelor's degree in a scientific or allied health field, or equivalent degree.
- Typically requires 6 years of experience, or an equivalent combination of education and experience.
- In-depth knowledge of the conceptual and practical application of cGMPs in a pharmaceutical setting, global GMP requirements, and support of GMP manufacturing.
- Strong team leadership skills and ability to work in a fast-paced environment while meeting quality, accuracy, and timeliness objectives.
- Ability to independently lead cross-functional teams and represent the Quality unit.
- Ability to communicate across functions to varied audiences, exchange complex and sensitive information, influence others, and gain alignment around proposed actions.
- Demonstrated ability to independently provide QA advice for large, multifaceted projects.
- Demonstrated ability to evaluate quality matters and make complex decisions using technical experience, advanced judgment, and analysis and synthesis of varied information; ability to work outside precedent and bring new perspectives to existing solutions.
- Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
- Strong experience with electronic document management systems, such as Veeva.
Nice To Haves
- Experience in early Phase to Phase 3 Analytical Quality.
Responsibilities
- Collaborate with internal and external business partners to resolve complex quality issues and ensure compliant solutions.
- Participate in cross-functional teams as an experienced Quality technical resource.
- Draft and enforce Quality Agreements between CMOs or suppliers and Vertex as needed.
- Assist Change Control owners in ensuring compliance with change procedure requirements.
- Assess and approve change controls.
- Conduct quality investigations and deviations, and review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for deviations and OOS investigations.
- Ensure appropriate CAPA actions are identified and addressed.
- Approve investigations and CAPAs.
- Identify, facilitate, and/or lead continuous improvement efforts.
- Maintain Quality Metrics to support process improvement activities.
- Provide tactics to address compliance gaps or determine enhancements to cross-functional quality systems.
- Conduct GMP document reviews, including procedures, work instructions, specifications, methods, protocols, and method reports.
- Coordinate, facilitate, and follow up on assigned QLT action items.
- Identify and communicate risks and assist with risk mitigation plans as necessary.
- Support internal audit or external audit programs.
- Manage audit CAPAs and metrics.
- Provide technical advice for partner and regulatory agency audits.
Benefits
- Overtime pay eligibility in accordance with federal and state requirements.
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What This Job Offers
Career Level
Senior
