Key Responsibilities

• Provide Quality oversight for GMP/GLP activities at Cerevel and its global vendors, which includes Contract Research Organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs).
• Apply cGMP principles and requirements in a phase-appropriate manner to support the development and manufacture of  commercial products while ensuring quality and compliance with Cerevel’s procedures and applicable health authority’s regulations.
• Review and approve GMP documentation, including Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors.
• Review and approve vendors’ executed batch records, analytical data, packaging and labeling records, to ensure timely disposition of drug substances, drug products and finished goods for use in commercial operations.
• Review, approve and track Cerevel’s and/or vendors’ product quality investigations, included but not limited to, deviations/nonconformances, CAPAs, out of trend (OOT), out of specification (OOS), product quality complaints, associated with manufacturing and analytical/stability testing.
• Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects’ timelines.
• Participate in and/or support Quality audits (internal and external) with the support of external quality consultants/auditors.  Support vendor qualification activities, which may include auditing and approving of GMP/GLP vendors, providing recommendations, and following up on audit responses and resolution of CAPAs.
• Ensure Cerevel and vendors are in compliance with US and Global regulations, guidelines and industry standards in countries where Cerevel conducts GxP activities. Serve as a Person-in-Plant (PIP) at vendors, when needed.
• Lead preparation for CDMO/CMO inspection readiness when required.
• Review CMC regulatory filings and supporting documentation, as needed.
• Develop and oversee GPQ metrics/KPIs and report results to Senior Management.
• Serve as GPQ Representative in collaborating with Information Technologies and Quality Management in the selection, implementation, and maintenance of GxP electronic quality management systems and applications (e.g., Veeva Vault – QMS).
• Support the development, implementation, and maintenance of Cerevel’s procedures and electronic Quality Management Systems.
• Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement – from defining business need, project planning, development, deployment, and end user adoption – and provide ongoing GMP functional oversight for all electronic quality management systems.
• Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization.

Required Qualifications

• 8+ years of relevant QA experience in pharmaceutical or biopharmaceutical industry in manufacturing, QA or QC role supporting GMP Activities for Investigational Medicinal Products and/or Commercial Products.
• In-depth knowledge of GMP/GLP QA principles and standards, as well as thorough understanding of FDA, EMA and ICH quality regulations necessary for day-to-day operations of commercial supply operations
• Experience in working and managing CDMOs/CMOs to conduct GMP manufacture, testing, packaging/labeling, and/or distribution.
• Experience in authoring and implementing SOPs.
• Experience with Regulatory/Health Authority Inspections
• Experience working in electronic quality management systems (Veeva or equivalent)
• Experience with electronic Learning Management Systems
• In depth knowledge of Validation Lifecycle requirements
• Understanding of GAMP Validation Guidelines and Validation lifecycle requirements
• Strong understanding of the Drug Development Process; ability to partner and build relationship with business function stakeholders and external vendors in order to enable high quality outcomes.
• Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs.
• Analytical problem solving and decision-making skills.
• Highly motivated, flexible and able to respond quickly to shifting priorities and 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 travel as needed, may be up to 30% domestic travel, occasional international travel may also be expected.

Desired Qualifications

• 2+ years of supplier quality experience managing GMP/GLP Vendors
• Previous experience working in a commercial Quality role.
• Desire to work in a fast-pace, dynamic environment.
• Strong team player with a solutions-oriented and customer-service mind-set
• Excellent interpersonal, problem solving with high degree of autonomy.
• Organized and efficient; delivers high-quality work.
• Experienced at leading teams and developing talent.
• Ability to coordinate timelines with internal customers and vendors.

Education

• Bachelor’s degree in life science (or equivalent) or engineering field relevant to pharmaceutical development; significantly more work experience in the relevant areas may be required for candidates without a bachelor’s degree.