Quality Lead

Job Description

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.

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.

Qualifications

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 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.

Preferred

• 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.

Required Skills:

Analytical Method Development, Analytical Method Development, Analytical Thinking, Aseptic Manufacturing, Biochemistry, Biological Sciences, Biotechnology, cGMP Compliance, Change Management, Clinical Decision Making, Decision Making, Driving Continuous Improvement, GMP Compliance, Immunochemistry, Laboratory Operations, Leadership, Lean Six Sigma (LSS), Microbiology, Motivation Management, Organic Chemistry, People Leadership, Pharmaceutical Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Compliance {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$156,900.00 - $247,000.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.