Manager, Clinical Manufacturing QA – Small Molecule

Responsibilities:
- Act as QA lead and single point of contact for managing small molecule products.
- Manage CMO quality relationships.
- Develop, implement, perform, and maintain Quality Systems and Incyte procedures.
- Support implementation of Incyte Quality Management Systems and Global Policies.
- Serve as knowledge manager for internal eDMS/eQMS and provide training when needed.
- Perform internal and external cGMP audits.
- Provide supplier GMP oversight per Incyte procedures, including supplier qualification.
- Negotiate quality agreements with third parties.
- Approve supplier GMP documents (e.g., master batch records, specifications, test procedures, validation and stability documents).
- Review and disposition of supplier-executed RSM intermediate (when applicable), drug substance, and drug product batches for clinical studies.
- Review and disposition of supplier-executed stability packaging batches.
- Initiate and maintain Product Specification Files (PSFs) for new and existing compounds.
- Manage supplier quality events (investigations, change controls, CAPAs, and complaints) for clinical development projects.
- Review regulatory documentation (e.g., NDAs, INDs, IMPD) and responses to Health Authority questions.
- Report and maintain Quality Management System metrics for assigned responsibilities.
- Manage and track controlled document distributions to external CMOs.
- Perform QA role in internal Quality Events records in Veeva (audits, deviations, CAPAs, change controls).
- Support and participate in regulatory agency inspections.
- Identify and alert QA Management of internal and external quality system issues.

Qualifications:
- Degree (e.g., Bachelor’s) in a scientific discipline (chemistry, biology, pharmacy, engineering, or related) or equivalent experience; advanced degree preferred.
- Experience in Quality Assurance in pharmaceutical/biotechnology with GMP focus for RSM, drug substance, and drug product manufacturing.
- Proven oversight experience from early development through validation and commercialization stages.
- In-depth knowledge of global regulatory requirements (FDA, EMA, ICH guidelines).
- Strong experience with process validation; quality systems (CAPA, deviations, change control); and supplier/CMO management.
- Strong project management and leadership; experience working with cross-functional teams and managing multiple projects in a fast-paced, highly regulated environment.
- Strong verbal and written communication skills.
- Willingness to travel up to 15% domestically and internationally (as needed).