Associate Director, Global Quality Assurance – Large Molecule Manufacturing and Analytical

18 hours ago

IND Telangana Hyderabad, India MSD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Description

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, Good 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 HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

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

    3 days ago

    Hyderabad, Telangana, India MSD Full time

    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...

  • Associate Director, Global Quality Assurance – Large Molecule Manufacturing and Analytical

    10 hours ago

    Hyderabad, Telangana, India MSD Full time ₹ 25,92,000 - ₹ 43,20,000 per year

    Job DescriptionRole 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,...

  • Associate Director, Global Quality Assurance – Large Molecule Manufacturing and Analytical

    10 hours ago

    Hyderabad, Telangana, India MSD Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job DescriptionRole 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,...

  • Associate Director Quality Assurance For Large Molecule Manufacturing Plant

    2 weeks ago

    Hyderabad, Telangana, India MSD Full time

    Job Summary The Quality Assurance Associate Director will support a technical team interfacing between our Company and External Partners in the Biologics Drug Substance and Drug product manufacturing area This individual will be responsible for ensuring that all quality assurance processes and compliance requirements are met during technical transfers to and...

  • QA Expert, Eso Large Molecules

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    **Summary**: Ensure that for all Novartis products - manufactured by external supplier in scope of personal portfolio - all aspects of manufacturing, testing, release and distribution/import comply with international standards of GMP, regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements. **About the Role**: **QA...

  • Associate Director – Technical Services Manufacturing Science

    3 days ago

    hyderabad, India Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Scientific Business Analyst

    4 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Information Systems Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our...

  • Sr Associate Software Engineer – Large Molecule Discovery

    3 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category Information Systems Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our...

  • Associate Director – Technical Services Manufacturing Science

    4 days ago

    Hyderabad, Telangana, India Eli Lilly and Company Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Director – Quality

    3 days ago

    hyderabad, India Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...