Job Description

Are you passionate about Quality Assurance and have a strong background in Drug Product & Drug Substance GMP manufacturing? In this role, you will be pivotal in ensuring GMP manufacturing meets all regulatory, cGMP, and company requirements. Your expertise will uphold our high standards of quality and contribute to the success of our programs. If you are dedicated to excellence in quality assurance, we welcome your application to be part of our innovative team.

Your Core Responsibilities

· Act as site QA responsible for onsite quality monitoring of DP/DS manufacturing and participate in GMP production activities.

· Support Technology Transfer, PPQ activities and monitor the quality of GMP production.

· Create, Review/ Approve department SOPs in collaboration with functional departments, ensuring alignment with corporate policies.

· Audit quality documents to ensure data integrity and provide QA guidance.

· Support site GMP Readiness activities

· Support self-inspection program and Health Authority Inspections as required

· Establish and manage the DP & DS QA Operations team, providing support and ensuring performance management requirements are met.

· Review and approve manufacturing-generated documents, ensuring compliance with regulatory standards.

Who You Are

You are ready if you have:

· Qualification Degree in Biopharmaceutical Science or other related science discipline.

· Knowledge of legislative, regulatory, market and data integrity requirements.

· Minimum of 8 years experience in vaccine/biopharma DP/DS Manufacturing. Desirable to have sterile DP filling experience.

· Proven track record in people management, problem-solving, with strong interpersonal skills.

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

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

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

· Strong communication skills with the ability to work in a matrix environment.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

 Preferred Skills:

Job Posting End Date:

*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:R339949