Manager, Quality Control

Job Description

Under the direction of the Site Quality Head, the QC Lab Manager is responsible for providing guidance and supervision to QC Specialists and Technicians to complete testing and testing support activities. Responsible for team development of experienced QC analysts, maintenance of a robust training program, and for facilitating a compliant and safe culture through policy deployment and application. This is a dynamic role in a fast-paced environment, with 12-15 direct reports.

Additional Responsibilities

• Manage, coach and mentor QC team to build technical expertise among the group. Build diverse talent with the capabilities necessary to succeed. Promotes collaboration, teamwork, and open communication

• Responsible for testing of final and bulk product, raw materials, and is knowledgeable in the analytical techniques for the laboratory(s) they support.

• Authoring, Reviewing, Revising and approval of SOPs, Quality Control Procedures, and other business critical documentation.

• Oversees QC training program to ensure employees are competent and qualified to perform duties.

• Critically evaluating data generated for product release and recommending acceptance or rejection of batches

• Maintain records, develop improvement plans, tracking functions such as corrective actions, special projects, etc.

• Leading and/or supporting Investigations, Root Cause Analysis, and CAPA implementation and effectiveness evaluations.

• Leading and/or supporting effective Change Control of processes and documentation.

• Investigating safety and environmental incidents and near misses. Model a safe and compliant culture throughout the laboratories.

• Support internal audits and regulatory lab inspections as a subject matter expert.

• Act as a resource and liaison between technicians and support groups to represent the needs of the laboratory.

• Initiate and follow-up on equipment repairs and follow-up on facility work orders for laboratory modifications.

• Required collaborating with Quality Assurance and Operations colleagues.

• Support hiring and onboarding of employees. Encourage development of direct reports to set and achieve objectives. Write and perform the performance evaluations of direct reports.

• Assist the Site Quality Head in the preparation of the annual budget. Prepare documentation for budgeted capital equipment and supplies.

• Participate in other special projects or activities as assigned by management.

• Advocate “Safety First, Quality Always” mindset by perform periodic Gemba walks in the laboratory and in other departments.

• Coordinate the preparation of QC metrics reports needed for management meetings and discuss results at department or inter-department meetings.

Education Requirements

• Minimum of Bachelor’s degree in biology, Microbiology, Virology, Biochemistry, or related field

Required Experience and Skills

• Minimum five (5) years of laboratory, manufacturing, or quality experience in a cGMP environment.

• Working knowledge in the biotech industry with specific understanding of QC operations, regulatory agency engagement and ability to gain alignment on strategy.

• Demonstrated principled verbal and written communications.

• Servant Leadership Mindset

• Excellent interpersonal communication skills

• Demonstrated ability or aptitude for continuous learning and analytical problem solving with experience in root cause analysis and CAPA deployment.

Preferred Experience and Skills

• Experience developing and improving methods for biological and/or biochemical assays.

• Continuous Improvement and Lean methodology experience.

• Strong knowledge of USDA, GMP, regulation regarding vaccine manufacture

• Assay validation methods and report writing.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R267555