Job Description

Join our company as a QC Lead and play a crucial role in ensuring the highest quality standards in our products and services. This is an exciting opportunity to lead a dynamic team, drive continuous improvement, and make a significant impact on our quality programs.

Your Core Responsibilities

Develop and lead a world-class cell-based potency assay QC team, including planning, recruiting, coaching, and training. This role will enable you to shape and enhance our team’s capabilities.

Serve as a technical expert to develop, qualify, and validate bioassay/cell-based potency methods for vaccines in a GMP environment.

Prepare, review, and approve technical documents such as method protocols and validation reports.

Provide technical guidance, evaluate new analytical technologies, and enhance department capabilities.

Oversee GMP quality oversight, including deviations, investigations, change controls, and CAPAs.

Manage lab scheduling and planning for Vaccines QC labs, ensuring streamlined workflows and operational efficiency.

Lead project management interactions with internal and external clients, including Quality Assurance and Regulatory Affairs.

Handle regulatory inspections and GMP audits, ensuring continuous improvement of QC quality systems and safety measures.

Who You Are

You are ready if you have:

Ph.D. or MSc in Microbiology related to immunology or Virology.

Strong understanding of analytical and QC operations in the biopharmaceutical/vaccine industry.

Proven track record in people management, problem-solving, and interpersonal skills.

Knowledge of current regulations and industry trends for vaccine development, manufacture, and testing, including cGMP, ICH, EMA, and FDA guidelines.

Proven ability to lead continuous improvement initiatives to enhance quality standards and operational efficiency within the QA potency team.

Exceptional skills in collaborating with cross-functional teams to integrate QA potency processes and address issues promptly.

Strong leadership skills, including strategic planning, innovation, and talent development, with a commitment to diversity, equity, and inclusion.

Nice to have, but not essential:

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.

Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.

Proven track record working cross-functionally across a wide variety of technical, business, and operational areas.

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.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

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):

Job Posting End Date:

05/1/2025

*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.

QC Potency Lead

Associate Director

Inventing for Life