Job Description

Are you an experienced professional passionate about quality control? Do you thrive in a fast-paced environment and want to contribute to advancing health solutions? If so, our company invites you to join our Quality Control department as a QC Lab Manager. This role is essential in leading our QC group, ensuring the highest standards of quality and compliance.

Your Core Responsibilities

Serve as a technical expert in developing, qualifying, and validating bioassay and cell-based potency methods for vaccines, supporting QC release and stability testing within a GMP environment.Prepare, review, and approve technical documents, including method protocols, qualification and validation protocols, and reports.Provide technical guidance to subordinates and evaluate new analytical technologies to enhance departmental capabilities.Support deviations, atypical/OOS investigations, change controls, and CAPAs.Lead the team and assist the Potency Lead in achieving departmental goals by streamlining workflows, optimizing processes, and ensuring full compliance.Manage regulatory inspections from FDA, EMA, and GMP audits from clients and internal Quality Assurance.Act as a point of contact for project coordination, including email and client meetings.Enhance QC quality systems and documentation, improve data integrity, and ensure the delivery of high-quality results.

Who You Are
You are ready if you have:

Bachelor, Master, or PhD Degree in immunology, virology, life science, analytical, or related discipline.Proven track record of strong people management, problem-solving, and interpersonal skills.Good understanding of analytical and QC operations in the biopharmaceutical/vaccine industry.Working knowledge of current regulations and industry trends for vaccine product development, manufacture, and testing, including cGMP, ICH, EMA, FDA, and other global regulations.

Nice to have, but not essential:

Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.Minimum of 8 years of vaccine industry experience preferred, or minimum 10 years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing.
 

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

As a company, we are committed to keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.  

 

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.  

 

So, if you are ready to: 

 

Invent solutions to meet unmet healthcare needs, please apply today. 

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

 Preferred Skills:

Job Posting End Date:

05/22/2025

*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.

Requisition ID:R339951