Manager, Commercial Manufacturing QA Small Molecules

SUMMARY

The Manager, Commercial Manufacturing QA Small Molecules is responsible for the Quality oversight of commercial manufacturing, packaging and testing activities associated with Small Molecules Drug substances, Drug Products and Primary Packaged Products.

The Manager assures compliance of assigned registered Small Molecules Products throughout their lifecycle, with cGMP requirements and registration files.

The Manager is responsible of assigned product(s) quality management as well as vendors oversight and performance & GMP compliance management.

The Manager maintains a strong collaboration with other QA / QP functions, Supply Chain and Technical Subject Matter Experts (SMEs), promotes continuous improvement and Quality culture.

The Manager ensures Product(s) quality related expertise to support change management, deviation and OOS.

Duties and Responsibilities

• Manage the day-to day quality oversight of assigned product(s), Commercial Contract Manufacturing Organizations (CMOs) and contract laboratories including GMP compliance and performance monitoring,
• Collect, review all records required for batch review, disposition and shipment and decide on batch dispositions,
• Maintain and control the Product Batch Records filling and databases,
• Assure compliance of Small Molecules Products by creating, approving and maintaining Product File specifications (PSF) and monographs,
• In partnership with Supply Chain, prepare and conduct Quality and Business Review (QBR) meetings with the assigned Commercial CMOs,
• Ensure QA oversight for all quality events related to the area of responsibility,
• Assure QA representative responsibilities for internal and external change control implementation,
• Assure QA representative responsibilities for internal and external CAPA implementation,
• Contribute to the Quality Risk Management process by providing input related to CMO compliance and performance and to Major and Critical quality events,
• Lead the Annual Product Review (APR) process for the assigned product(s), collect and review the CMO and license partner APRs and issue Incyte APRs for the manufacturing activities in collaboration with other QAs and QPs,
• Ensure implementation of Continued Process Verification at assigned Commercial CMOs,
• Support Product stability programs for Registered Small Molecules Products,
• Establish and maintain Quality and Technical Agreements with assigned Commercial CMOs,
• Perform internal and external audits according to Incyte audit program,
• Support Health Authority Inspection Readiness Programs and inspection management at assigned CMOs, license partners and Incyte,
• Support Incyte and license partners regulatory submissions as well as product launches,
• Cooperate with the Supply Chain, Analytical, Process and Packaging SMEs and Regulatory Affairs functions on Commercial Small Molecules Product related activities, provide QA input where and when necessary,
• Promote Quality and GMP/GDP initiatives, withing and beyond global quality, 
• Stay current with applicable regulations and contribute to the regulatory watch process, ensure Ambassador role for at least one assigned subject,
• Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements,
• Contribute positively to a strong culture of business integrity and ethics,

Requirements

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering),
• Experience of minimum eight years in Pharmaceutical and/or Biopharmaceutical industry,
• Positive and strong leadership attitude in line with Quality oversight expectations, challenge status quo
• Experience in CMO Quality oversight,
• Thorough knowledge of cGMP, and global regulatory requirements applicable to pharmaceutical manufacturing and testing including qualification and validation,
• Experience with the management of health authority inspections,
• Auditor qualification is a plus,
• LEAN qualification (e.g. Green Belt) is a plus,
• Proficiency with Quality and ERP systems, experience with Veeva and SAP are a plus
• Results focused with good interpersonal skills, diplomacy, negotiation skills and common sense,
• Strong verbal and written communication skills with structured communication and presentation ability,
• Compliance focused whilst assuring a pragmatic and risk based approach to quality,
• Ability to manage multiple projects, to make pragmatic and compliant decisions,
• Fluent in English, French is a plus,
• Flexibility and ability to travel up to 20%.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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