Sr. Director, Supplier 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, caregivers and themselves.

Join us, as we reshape the future.

Job Summary:

The Sr Director, Supplier Quality provides cross-functional support for GXP activities as they relate to Supplier Quality. This position will provide comprehensive oversight and monitoring compliance for all applicable regulations and procedures with supplier on-boarding, management of suppliers, and driving strategic improvements to Supplier Management Program.

This position is based in our Framingham location and typically has a 4-5-day on-site expectation.

Responsibilities

• Develop, implement, sustain, and improve quality strategy, plans, and risk-based thinking.
• Oversee compliance to meet global regulations, guidelines, ICH, ISO and other requirements, while maintaining strategic development, execution, and oversight of all supplier quality programs across Replimune.
• This role is accountable for building strong partnerships with suppliers, driving quality improvements, and following all operational and quality standards.
• Enhance Supplier Management program by working closely with Quality Compliance, Quality Systems, Supply Chain, Clinical Operations, Legal & Contracts, and Operational QA to ensure requirements and internal processes support best practices.
• Ensure that regulated processes and systems at Replimune are phase appropriate and inspection ready.
• Develop and execute the global supplier quality strategy aligned with the company's operational goals.
• Recruit, develop, train, and mentor staff such that they have the education, training, experience, or any combination thereof to perform their job functions.
• Lead initiatives to assess, qualify, and monitor the performance of suppliers. Oversee the development of supplier quality agreements, ensuring that all standards and specifications are clearly communicated.
• Provide direction and coordination of all activities and with other functions that influence Supplier Quality Program and impact to manufacturing of our products and clinical trial supplies.
• Drive risk management to identify and mitigate risks within the supply chain.
• Collaborate with internal stakeholders such as supply chain, operations, quality compliance, procurement, product development, QC and operational QA to drive improvements with certain underperforming suppliers.
• Lead Supplier Quality Board and Supplier Change Notification activities to serve as a key point of contact for supplier-related issues, leading the resolution of complex quality issues in coordination with relevant departments.
• Establish KPls and metrics and track supplier performance driving accountability and improvements
• Assessment of trending for all key KP ls
• Report on the performance of the suppliers during regular Quality Councils

Qualifications

Education:

• Bachelor's or master's degree preferably in the life sciences with practical experience in a regulated manufacturing environment or equivalent experience
• A minimum of 12+ years of relevant experience required, with at least 5 years of experience in leadership role

Required Experience:

• Highly motivated individual with excellent time management skills.
• Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
• Successful track record of preparing for pre-approval regulatory inspection(s).
• Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Knowledge of Supplier Quality Management program.
• Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products
• Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
• Excellent written and oral communication skills.
• Ethical, self-motivated and self-directed.

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.