GDP Operational Quality Manager, 12 month contract
The GDP Operational Quality Manager is an internal technical resource in the application of quality assurance and compliance principles to a wide range of disposition activities. The Manager coordinates or executes activities on multiple projects and takes a role in the design and execution of new projects.
Key Duties and Responsibilities:
- Provide quality oversight and support to operations at the Vertex Annex Drug Product Facility in the following key areas: support of manufacturing operations across all phases (development and commercial), support of analytical laboratory operations, and materials management.
- Oversee commercial and clinical batch disposition process. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
- Approve clinical and commercial lot COAs, generating BSE/TSE statements and product labelling
- Archive batch records and other supporting documents
- Generate and analyze performance metrics and trends, including site metrics for disposition, investigations, CAPA, etc.
- Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and consequential quality issues; provide direction for product disposition decisions including shipment.
- Review and approve Manufacturing documents e.g. MCR, MBR, Recipe, Engineering Parameters etc.
- Affirm raw material release, area clearance and equipment release.
- May assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
- Provide QA support of development and commercial change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
- Lead compliance walkthroughs of the site and help close any observations.
- Identifies risks, communicates gaps, and recommends optimized processes for GMP process/systems, area/equipment release, material disposition, etc.; execute process improvement initiatives to realize efficiency gains
- Support new product introduction into the Drug Product Facility by reviewing and approving new MBRs and material master files.
- Participate in inspection readiness activities and provide support during regulatory site inspections.
- Provide important compliance guidance to business owners; cultivate productive, collaborative relationships and mutual understanding of business needs
Knowledge and Skills:
- Strong foundation and demonstrated experience in:
- providing QA support and oversight of GMP manufacturing operation including batch release
- drug product development and manufacturing
- cGMPs and associated CMC regulatory considerations in a pharmaceutical environment
- Equipment, facilities and utility system qualifications under cGMP
- Leading event investigations, Root Cause Analysis (RCA), and CAPA
- Applications such as Oracle and TrackWise
Education and Experience:
- B.S in scientific or allied health field
- Typically requires experience or the equivalent combination of education and experience
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.
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 ApplicationAssistance@vrtx.com.