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Director Quality Assurance

15+ years
Not Disclosed
10 July 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Director – Quality Assurance

Location: Baddi, Himachal Pradesh, India
Category: Quality | Full-time


Job Summary:

We are seeking a highly experienced and strategic Director – Quality Assurance to lead QA and QC operations at our state-of-the-art pharmaceutical manufacturing facility in Baddi. This role is critical in shaping quality systems for Oral Dosage Forms (ODF), Large Volume Parenterals (LVP), and Hormone blocks. The ideal candidate will drive GMP compliance, lead regulatory inspection readiness, and elevate site-wide quality performance to global standards.


Key Responsibilities:

  • Develop QA/QC strategies for ODF, LVP, and hormone blocks ensuring compliance and efficiency

  • Lead GMP improvement initiatives across facility systems and procedures

  • Prepare and manage departmental budgets (CapEx and OpEx)

  • Set and monitor KRAs for QA and QC departments

  • Ensure inspection readiness for regulatory, corporate, and customer audits

  • Implement corrective and preventive actions (CAPA) in response to audit observations

  • Drive adherence to Abbott’s global policies and procedures

  • Conduct internal audits and oversee Pharmaceutical Quality System (PQS) reviews

  • Ensure regulatory documentation submission and compliance

  • Implement site-wide cybersecurity protocols relevant to quality functions

  • Maintain a GxP-compliant document control system

  • Oversee batch release processes, ensuring alignment with regulatory and internal policies

  • Approve or reject raw materials, intermediates, and finished products

  • Manage product recalls in coordination with Regional Quality teams

  • Lead review meetings with senior management for continuous improvement

  • Mitigate and communicate product quality risks based on scientific evaluation

  • Oversee site-wide documentation, deviations, exceptions, and change controls

  • Ensure comprehensive training on GMP, GDP, and GLP standards

  • Maintain updated documentation per regulatory/pharmacopeial revisions


Required Skills & Qualifications:

  • Bachelor's or Master’s degree in Pharmacy, Life Sciences, or related discipline

  • Minimum 15 years of experience in pharmaceutical QA/QC, with leadership experience

  • Strong knowledge of GMP, GLP, GDP, QMS, audit handling, and regulatory guidelines

  • Experience in managing multisite QA/QC teams preferred

  • Proficient in document control systems and CAPA management

  • Demonstrated success in regulatory inspections (USFDA, MHRA, WHO, etc.)

  • Familiarity with pharmacopoeial standards and updates (USP, EP, IP)

  • Excellent communication, leadership, and stakeholder management skills


Perks & Benefits:

  • Competitive compensation (salary not disclosed)

  • Executive leadership role with strategic decision-making authority

  • Opportunity to lead quality at a globally recognized pharma facility

  • Exposure to international regulatory standards and practices

  • Comprehensive health and wellness benefits

  • Dynamic team culture and continuous professional development


Company Description:

This opportunity is with a top-tier pharmaceutical manufacturer in Baddi, renowned for its advanced facilities and robust global quality standards. The company focuses on producing high-quality dosage forms with strict adherence to GMP, serving patients and partners worldwide.


Work Mode: On-site (Baddi, Himachal Pradesh)


Salary Range: Not specified in the job description


Call to Action:

Ready to lead quality excellence at a world-class pharma facility? Apply now and take your pharmaceutical quality leadership career to the next level.