Quality Lead

Merck•Upper Gwynedd Township, PA

3d•Hybrid

About The Position

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and contribute to our mission of making a difference in global health. Large Molecule Analytical Sciences Quality 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 Quality is specifically focused on quality oversight for large molecule drug substance and drug product commercial support, Biological Critical Reagents, Analytical Method Transfers, and analytical product lifecycle activities. Responsible for demonstrating operational leadership with compliance, safety, customer service, and productivity initiatives while assuring that all applicable regulatory and environmental regulations are adhered to. The Director, Quality Lead, is responsible for management, execution and leadership of quality activities to ensure the GQLMAS Quality team provides oversight of LMAS to ensure compliance with cGMPs, applicable worldwide regulations, and company requirements for supported area(s). The Director is also responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations. Additional responsibilities include supporting the development of capacity planning and annual Profit Plans and ensuring department financial goals are met. The Director may also operationally supervise staff and develop talent in accordance with employee development plans and business priorities.

Requirements

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 experience in a management/leadership role directly related to Quality Assurance, Quality Control, 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 teams located remotely.
Strong analytical and problem-solving skills with proven ability to make decisions in a constantly changing environment.

Nice To Haves

Advanced degrees in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, or Microbiology (Master’s degree with eight (8) years of required experience; PhD with four (4) years of required experience).
An MBA or other business degree, qualification in Lean Six Sigma/MPs/CI.
Proven capability as a leader operating at both a strategic and operational level.
Proven track record of delivering high performance through program/project leadership.
Demonstrated ability to fully realize change and improvement initiatives.
Demonstrated leadership behaviors (refer to our company key behaviors).
Stakeholder management of multiple decision-makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels while working in partnership with stakeholders across boundaries.

Responsibilities

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 for supported area(s).
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 areas to applicable worldwide regulations and industry standards.
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 related to specialized area of technical expertise, specifically for analytical areas.
Ensure departmental SOPs reflect departmental procedures and the current regulations.
Oversee SOPs in supported areas and ensure periodic updates, as appropriate.
Manage the review and/or approval of Impact Assessment Form(s) 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 our 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.