Operational Quality Assurance Manager- Stability- HYBRID

Job Description

The Operational Quality Assurance Manager- Stability is a technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The Stability manager collaborates on internal technical operations team, serves as primary QA contact, and leads the coordination of GMP activities in support of commercial stability.

This position reports directly to Associate Director, Analytical Support - GMP Operational Quality.

Key Duties and Responsibilities may include but not limited to, the following:

• Lead commercial stability program - Review/approve Stability studies, plans, Vendor Protocols, and maintain internal stability data trackers for assigned product/program
• Review of analytical data associated to Commercial Stability testing
• Quality oversight and Management of Laboratory data management system for commercial stability
• Support regulatory filing reporting and inquiries (as needed)
• Provide backup support for other lead commercial projects when requested/needed
• Review of analytical data associated to method validation and tech transfer activities
• Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions. Evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions when needed
• Perform qualification of CMOs/CTLs for reduced review certification.
• Review and approval support for Quality events - Deviations, OOS Investigations, CAPA and change controls assessments and closure approvals
• Lead root-cause analysis and product impact assessment for investigations because of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
• Establish and revise Quality Agreements between CMOs/CLOs/Suppliers and Vertex, as needed
• Collect raw data and provide support to QA management with quarterly commercial metrics
• Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
• Assist with internal audits and external regulatory agency inspections when needed
• Identify and facilitate continuous improvement efforts and Lead continuous improvement projects as assigned.
• Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills, exchanging complex information and influencing/guiding others to understand a stated viewpoint
• Manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes

Education and Experience:

• Bachelor's degree in scientific or allied health field (or equivalent degree)
• 4 - 6 years of experience or the equivalent combination of education and experience
• Working knowledge of GMP regulations and applicability to duties.
• Operational QA experience in analytical or manufacturing setting,
• interpretation, and application of GMPs and applicable guidelines/guidance's ex. ICH, USP, etc.
• Working experience with external CMOs and providing quality oversight
• Experience in Oral Solid Dosage forms (Analytical and stability is preferred)

Analytical Experience:

• Analytical data review/approval, deviation/investigations, change control, and Quality System background helpful.
• Experience in basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
• Ability to understand technical processes, Knowledge, and application of risk management principles/ Risk Impact evaluation-aligning effort to level of risk
• RCA tools/methodology/ technical writing
• Facilitation/ problem solving /organizational, planning, etc.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at (see application details).