Director, Quality Assurance Validation

Scorpion Therapeutics; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

A leading pharmaceutical company seeks an experienced Quality Assurance Manager for its Framingham location. The role entails overseeing validation activities, ensuring compliance with regulations, and fostering strategic partnerships across teams to uphold data integrity and quality standards.

Qualifications

• Minimum 5-8 years for Senior Manager role, or 8-10 years for Associate Director.
• Experience in a regulated manufacturing pharmaceutical environment required.

Responsibilities

• Ensure compliance with validation practices across the GMP organization.
• Lead validation best practices in line with FDA, ICH, NIST and PICS.
• Serve as a subject matter expert in Validation and support quality system initiatives.

Skills

Data Integrity

Validation Best Practices

Quality Oversight

Education

Bachelor's degree in life sciences

Job description

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Replimune’s Mission

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.

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

This role provides cross-functional support for GxP activities as they relate to validation activities throughout the GxP organization. This position will provide comprehensive mentoring, oversight and monitoring of compliance for all applicable regulations spanning operations and IT relating to achieving and maintaining the validated state of facilities, utilities and equipment.

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

Responsibilities

Key Responsibilities:

• Responsible for Quality oversight of validation and qualification activities ensuring accurate, consistent, and complete validation life cycle requirements are in place and followed throughout the GMP organization in Framingham.
• A critically important aspect of this role is application of validation best practices following FDA, ICH, NIST and PICS.
• Over time, data must be maintained across formats. This is a continual process involving various processes, rules, and standards.
• Represent QA on diverse project teams ensuring development, implementation, maintenance of compliance strategy with an emphasis on risk-based approaches with a quality mindset.
• As it relates to data handling and computer systems, ensure global alignment of computer systems access and data handling solutions with supporting validation and process validation(s) across GxP sites and regulated areas.
• Delivery of shared efficiencies and optimization for shared services relating to data integrity ensuring principles of data integrity are considered in operational design and day-to-day GxP operations.
• Facilitate the roadmap of activities needed to ensure and maintain data integrity controls and their effectiveness and continuous improvement agenda in a compliant manner.
• Lead and deliver system(s) practices and procedures with assurance of data integrity.
• Emphasize consistent use of tools such as data process mapping and risk analysis to support data-driven and risk-based approaches.
• Serve as a subject matter expert in Validation and the Validation Life Cycle across operations and quality, supporting cross-functional initiatives throughout the Quality System.
• Responsible for developing strategic and collaborative partnerships with the partner enterprise team, validation team, risk management, and operations leadership.
• Maintain a trusted partner relationship and advisor to all stakeholders.

Other Responsibilities:

• Additional Responsibilities as required.

Qualifications

Education:

Bachelor's degree required in the life sciences.

Required Experience:

• Senior Manager: A minimum of 5-8 years of relevant experience required with practical experience in a regulated manufacturing pharmaceutical environment or equivalent experience.
• Associate Director: A minimum of 8-10 years of relevant experience required with practical experience in a regulated manufacturing pharmaceutical environment or equivalent 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.