The Associate Director, Plant Quality Assurance (PQA) is responsible for the development, implementation and maintenance of Quality Assurance systems and activities at Replimune, with a focus on GMP production. Ensures all relevant quality and regulatory requirements are met for product manufacture and testing. Ensures site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies where Replimune clinical or commercial products are in use. Responsible for the evaluation and assurance that the validation of the aseptic qualification (media fill) program is maintained. Develops and manages the QA staff performing batch review, aseptic process monitoring and other compliance functions.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Key Responsibilities:

• Oversees Plant Quality Assurance functions ensuring the inspection ready status of the aseptic qualification (media fill) program.
• Ensures that GXP systems are inspection ready and manages inspection readiness activities.
• Oversees and provides direction for the Plant Quality Assurance staff and ensures QA release, compliance and documentation functions are performed effectively.
• Interface with internal customers in Research, Product Development, Quality Control and Manufacturing/Operations.
• Oversees or facilitates Replimune's PQA interactions with external vendors such as contract manufacturing organizations, and other service providers to ensure compliance with Replimune requirements and GXP quality standards.
• Provide support to Chemistry & Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company's products.
• Interface with Manufacturing and Quality Control to ensure on time batch review and disposition of Replimune clinical and commercial products.

Other Responsibilities:

• Ensures PQA staff is appropriately trained on an ongoing basis and maintain complete training records.
• Sets objectives for and appraises PQA staff
• Support Replimune Compliance activities to maintain an inspection ready status
• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to product specifications, standard operating procedures, validation documents, technical reports, quality policies, etc.
• Provide input in the establishment and implementation of validation philosophies and strategies to ensure a cGMP compliant program.
• Maintain up to date compliance knowledge and advise Replimune senior management accordingly.
• Other duties as required

Educational requirements:

• BS or B.S. degree in an appropriate scientific field. M.S., Ph.D. or other post­ graduate degree is encouraged.

Experience and Skill Requirements:

• 10-15 years'  experience in relevant  Quality Systems, technology and  management in a regulated biotechnology or pharmaceutical industry environment.
• Proven leadership in managing and motivating administrative and technical staff with strong awareness of the interface among Quality Assurance, Quality Control, manufacturing operations, and pre-clinical development.
• Appropriate GXP training.
• Knowledge of FDA and MHRA guidelines regarding GMPs.
• Excellent verbal and written communication skills.
• Good organizational skills.
• Computer literacy (including MS Word and Excel).

Location: 

• This position is based in our Framinghamlocation and typically has a 5-day on-site expectation.