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.
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