Job DescriptionAre 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 ResponsibilitiesAct 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 activitiesSupport self-inspection program and Health Authority Inspections as requiredEstablish 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 AreYou 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.Required Skills: Achieving Objectives, Achieving Objectives, Adaptability, Biopharmaceuticals, Biopharmaceutics, CAPA Management, cGMP Regulations, Communication, Compliance Analysis, Compliance Assurance, Corrective Action Management, Deviation Management, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Leadership, Management Process, Manufacturing Compliance, Organizational Performance Management, People Leadership, Pharmaceutical Manufacturing, Quality Assurance (QA), Quality Control Management, Quality Manuals, Quality Risk Management {+ 4 more}Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HERESearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:02/23/2026*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.