Description
Role Summary:
The Manager, GMP Vendor Quality Management will maintain and utilize processes, quality systems, and tools to qualify and monitor outsourced GMP activities and GMP Vendors that are utilized in the manufacturing, packaging, labeling, testing, warehousing, and distribution of finished pharmaceutical products and investigational medicinal products.
\n- Support and maintain the Cerevel GMP Vendor Management Program. This includes arranging contract auditor(s), assuring training documentation of the auditors is obtained and sustained to meet training requirements
- This position is accountable for timely receipt of audit reports, organizing internal review or audit reports, issuance of audit reports to vendors, obtaining vendor responses, and closure of audits in a timely manner to support business needs and meet timing requirements of Cerevel procedures
- Ensure assigned audits are 1) scheduled and conducted, 2) audit documentation is accurate and complete, 3) audit reports are sent to vendors, 4) acceptable responses are received from vendors, and 5) audits are closed out in Veeva as per respective procedures and timing
- Ensure all assigned GMP vendors are appropriately qualified
- Manage assigned Quality Agreements including their initiation, generation, and approval. Ensure that Quality Agreements are written, approved and in-place for external GMP vendors. Manage periodic reviews of assigned Quality Agreements
- Support Sr. Manager, with execution of the GPQ Internal Audit Program
- Ensure compliance with Cerevel requirements as well as applicable regulatory requirements
- Provide necessary inputs to support reporting of key performance indicators, metrics, and compliance status of GMP Vendors to Global Quality senior management
- Identify process improvement opportunities within the Vendor Management program to strengthen compliance and increase efficiency. Participate on continuous improvement projects related to the Vendor Management program
- Support inspections and inspection readiness activities associated with the Vendor Management program
- Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization
- At least 5 years of relevant Quality Assurance Vendor Management experience in a pharmaceutical industry
- Experience in the qualification and management of vendors for oral solid dosage forms both Clinical and Commercial purposes. This includes CMOs/CDMOs, API manufacturers, primary/secondary packagers and labelers, contract laboratories, warehouses, and distributors
- Experience supporting Health Authority Inspections
- General understanding of how the Drug Development Process impacts vendor qualifications
- Experience working in an electronic quality management system (Veeva or equivalent)
- Highly motivated, flexible, and able to respond quickly to shifting priorities. Able to meet deadlines, with excellent organizational skills and keen attention to details
- Strong verbal and written communication skills to effectively communicate with business functions and vendors
- Ability to partner and build relationships with technical operation stakeholders and external vendors to enable high quality outcomes
- Ability to travel up to 20% domestic travel, occasional international travel may be expected
- ASQ Certified Quality Auditor certification, or equivalent
- Prior experience qualifying vendors for sterile manufacturing a plus
- Strong team player with a solutions-oriented, customer-service, and continuous improvement mind-set
- Excellent interpersonal and problem-solving skills
- Ability to coordinate timelines with internal customers and vendors
- Bachelor’s degree in life science or engineering field; significantly more working experience in the relevant areas may be required for candidates without a bachelor’s degree
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