Manager, Plant Quality Assurance - Replimune, Inc.

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care becausepatient’s lives depend on it. We imagine a world where cancer is a curable disease. 

 At Replimune, we live by our values: 

United: We Collaborate for a Common Goal. 

Audacious: We Are Bold and Innovative. 

Dedicated: We Give Our Full Commitment. 

Candid: We Are Honest With Each Other. 

People are at the center of everything we do, and when it comes to our employees, we make it personal.  With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute tothe meaningful work we do which could impact the lives of patients, caregivers and themselves.  

 Join us, as we reshape the future. 

Job Summary: 

The Manager, Plant Quality Assurance (PQA) reports to the Associate Director, Quality Assurance and is responsible for on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing practices (cGMP), good documentation practices (GDP) and other applicable regulations. The Manager, PQA will ensure the maximum floor coverage for production lots (drug substance and drug product) in a timely and effective manner. The Manager, PQA will provide leadership, direction and delegation of work to PQA staff. This position interacts with production staff and other cross functional groups routinely.

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

Key responsibilities:

• Oversee and provide compliance guidance during on-the-floor processing.
• Work alongside manufacturing teams to ensure current and best practices are implemented.
• Oversees and provides direction for the Plant Quality Assurance staff and ensures QA release, compliance and documentation functions are performed effectively.
• Conduct process review of EM data supporting the manufacturing facility and ensure the program remains fit for purpose.
• Ensure facilities, equipment, materials, manufacturing organization, processes and procedures comply with cGMP practices and other applicable regulations.
• Drive closure/completion (including review and approve) of cGMP documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validation documentation.
• Establish and communicate departmental team member’s individual performance expectations and objectives.
• Author/review/approve quality documents, such as: standard operating procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental protocols/reports, validation protocols/reports.

Other responsibilities

• Internal and external audit and inspection support
• Complete required assigned training for self, and ensure training of staff, to permit execution of required tasks
• Drive operational improvement initiatives, programs and projects.
• Other duties, as assigned.

Education:   

• BA or BS in a Science or related field or equivalent experience in the Quality function.

Required Experience: 

• 8-10 years of experience in the pharmaceutical field including 5 years of years of Quality or Manufacturing experience
• Experience in managing multiple, competing priorities in a fast-paced environment.
• Experience leading and/or managing teams.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations)
• Previous Quality Assurance oversight experience

About Replimune  
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. 

We are an Equal Opportunity Employer.