Role Summary The Analytical Quality Assurance Specialist will provide QA oversight for analytical activities at contract manufacturing organizations CMOs Contract Testing Laboratories CTLs supporting large molecule biologics manufacturing This role ensures compliance with global regulatory requirements and internal quality standards while collaborating closely with and CMOs CTLs to maintain data integrity and product quality Key Responsibilities Oversee analytical operations at CMOs and CTLs for large molecule drug substance and drug product manufacturing Review and approve analytical method validation transfer and verification protocols reports from external partners Ensure compliance with GMP ICH WHO and country-specific regulatory guidelines for biologics Monitor and approve stability study protocols data trending and reports from CMOs CTLs Perform data integrity assessments for analytical instruments and electronic systems at partner sites Support investigations deviations and CAPAs related to analytical activities at CMOs Collaborate with internal teams and external partners to ensure timely resolution of analytical issues Participate in audits and regulatory inspections at CMOs and CTLs providing analytical QA support Maintain change oversight for analytical methods and specifications across partner sites Drive continuous improvement initiatives in analytical QA processes for outsourced operations Required Skills Adaptability Adaptability Analytical Validation Biological Manufacturing Change Management Collaborative Development Communication Cross-Cultural Awareness Cross-Functional Teamwork Data Integrity GMP Compliance GMP Training Positive Distribution Practice GDP Inspection Readiness Integrity Management IS Audit Leadership Manufacturing Compliance Manufacturing Quality Control Pharmaceutical Quality Control QC Quality Assurance QA Standards Quality Auditing Quality Management Standards Quality Metrics Quality Standards 4 more Preferred Skills Current Employees apply Current Contingent Workers apply Secondary Language s Qualifications Experience Education Master s degree in Pharmaceutical Sciences Chemistry Biochemistry or related field Experience 15 years in Quality Assurance or Quality Control in biologics large molecule manufacturing Strong understanding of analytical techniques HPLC ELISA PCR etc and method validation principles Experience in contract manufacturing oversight and collaboration with external partners Skills Excellent knowledge of GMP and data integrity principles Strong communication and stakeholder management skills Ability to manage multiple priorities and work in a fast-paced environment Preferred Experience with monoclonal antibodies vaccines or other biologics Exposure to electronic systems LIMS Empower Digital applications implementations 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 Hybrid Shift Valid Driving License Hazardous Material s Job Posting End Date 12 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

📌 Associate Director, Global Quality Assurance – Large Molecule Manufacturing And Analytical (Hyderabad)
🏢 Msd
📍 Hyderabad