Quality Lead

Job Overview

At our company, we aspire to be the premier research‑intensive biopharmaceutical company. We use leading‑edge science to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals, saving and improving lives around the world.

Large Molecule Analytical Sciences Quality (LMAS) is part of the Global Biologics Quality Organization and is responsible for technical, operational and strategic quality oversight of a growing and fast‑moving large‑molecule pipeline. LMAS focuses on quality oversight for large‑molecule drug substance and drug product commercial support, Biological Critical Reagents, Analytical Method Transfers, and analytical product lifecycle activities.

The Director, Quality Lead is responsible for management, execution, and leadership of quality activities to ensure the GQLMAS Quality team provides oversight of LMAS, ensuring compliance with cGMPs, applicable worldwide regulations, and company requirements. The Director provides assessments to senior management regarding compliance status and risk posture, supports capacity planning and annual profit plans, and operationally supervises staff while developing talent.

• Manage, execute, and lead quality activities to ensure the GQLMAS Quality team provides oversight of LMAS to ensure compliance with cGMPs, applicable worldwide regulations, and company requirements.
• Provide assessments to senior management regarding the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations.
• Support the development of capacity planning and annual profit plans, ensuring department financial goals are met.
• Operationally supervise staff and develop talent in accordance with employee development plans and business priorities.
• Stay informed of current GMP requirements and industry trends in the large molecule, analytical area to keep regulations and standards up to date.
• Provide comments on proposed regulations and communicate impacts to client areas using a risk‑based, phase‑appropriate approach for decision making.
• Maintain an expert level of knowledge in specialized technical areas, specifically analytical science.
• Ensure departmental SOPs reflect procedures and current regulations.
• Oversee SOPs in supported areas and ensure periodic updates, as appropriate.
• Manage the review and/or approval of Impact Assessment Forms for deployment/updates of Global Quality Manual topics as it relates to LMAS.
• Represent the department or area on project teams or committees establishing GMP or quality standards, policies or expectations within the company.
• Support and/or lead a team of professionals to execute on quality oversight deliverables for large molecule drug substance analytical product lifecycle.
• Apply technical/quality expertise to help teams remove obstacles, overcome technical challenges, and make impactful clinical disposition decisions.
• Review and approve analytical documents and deviation events.
• Participate in quality audits.
• Collaborate with peer leaders in LMAS Quality Operations to drive strategic initiatives and continuous improvement opportunities.
• Contribute to the establishment and sustainability of a safety‑first, compliance‑always culture.
• Develop and maintain an operational budget for the department.
• Serve as a representative for the team in both Global Biologics Quality and the LMAS leadership team.
• Develop and enhance the skills of the team.

Required

• Bachelor's degree in a science or engineering field of study.
• At least ten (10) years of leadership experience in the pharmaceutical industry or a similar operating environment, including a management/leadership role directly related to Quality Assurance, Quality Control, or Analytical Support.
• At least five (5) years of significant leadership experience directly related to Biologics and Sterile Quality.
• Strong understanding of cGMPs, cGDPs, including FDA, EMA, Health Canada, TGA, and PMDA.
• Demonstrated people management skills working with diverse, remotely located teams.
• Strong analytical and problem‑solving skills with proven ability to…