Director/Senior Director, External Quality

Overview

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 because patient’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 to the meaningful work we do which could impact the lives of patients.  

 Join us, as we reshape the future. 

Job Summary: 

The Director/Senior Director, External Quality will be responsible for Quality oversight of Investigational Medicinal Product (IMP) distribution and commercial product distribution. This leader will advance and provide quality expertise and knowledge supporting product launch and commercial readiness such as labelling requirements, 3PL vendor quality oversight, and management of Replimune’s complaint process.

This leader will have a broad role working cross functionally with supply chain operations, clinical operations, and commercial operations, fostering strong collaboration and partnership with external and internal stakeholders.

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

Responsibilities

Key responsibilities:

• Responsible to ensure Replimune internal operations and external vendors for supply distribution meet Good Manufacturing Practices, Good Distribution Practices, and other applicable requirements for IMP and Commercial Drug Product
• Establish robust Quality Processes/Process Ownership for product shipping, storage and distribution, ensuring  continuous improvement while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations.
• Provide quality oversight of global distribution to support clinical trial supply activity and commercial supply distribution, such as shipment, storage at depots/sites/customers and return for disposal, temperature excursion handing. Provide quality oversight of distribution and storage logistics issues.
• Provide Quality Leadership to cross functional improvement projects related to product distribution to ensure product quality and patient safety. Utilize strong strategic planning, influencing, operational excellence and execution skills to work with internal and external partners, sites and customers, to troubleshoot challenges, drive for root cause, evaluate risks, and implement improvements. 
• Participate in product launch activities to ensure that Supply Quality related actions are planned into projects and completed in line with the commitments. Examples of Supply Quality related actions: provide quality assessment of labelling requirements, provide quality input into distribution license requirements, perform qualification of distribution vendors.
• Set up of Quality Agreements for applicable vendors.
• Management of product complaints, complaint investigations, and responses to complainant.
• Creation and management of Standard Operating Procedures, change controls, deviation investigations and CAPA within their respective area
• Coordination of Biologic Product Defect Reports.
• Prepare topics and ensure readiness of quality system for internal audits and external Regulatory inspections.
• Provides leadership and partners with QA management team in proactive and strategic planning for QA and translation of the strategy to operating plans for execution
• Other duties as assigned.

Other responsibilities:

• Recruit, hire, develop, and retain qualified staff who embrace culture and core values, and increase organizational performance.
• Manages staff and ensures the roles are performed effectively.
• Ensures that staff are appropriately trained on an ongoing basis and have complete training records.

Qualifications

Education:   

• A or B.S. degree in an appropriate scientific field.
• S., Ph.D. or another post-graduate degree is encouraged.

Required Experience: 

• 8-12 years’ experience in a quality role in a regulated biotechnology or pharmaceutical industry environment, with strong experience in Good Distribution Practice and/or Quality support of commercial launch for a life sciences organization supporting development programs
• Experience with labeling and packaging requirements, and global cold chain distribution quality oversight is preferred.
• Direct experience with change control, deviation investigations, complaint investigations,
• Proven leadership in developing individuals and teams and managing staff to achieve goals through empowering teams.
• Demonstrated strategic planning and execution skills with a willingness to do hands on work to design/evolve and /or implement quality strategies and operational planning and oversight in a risk based and fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business
• Knowledge and demonstrated experience in application of risk-based quality principles in a biotechnology and pharmaceutical environment
• Broad and deep global health regulatory agency knowledge and experience across with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness.
• Excellent verbal and written communication skills with demonstrated ability to influence cross-functionally complemented with strong change management experience, adaptability, resourcefulness
• Operational Excellence experience with proven ability to lead improvement projects is desired

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. 

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