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General Manager – QC

Job Type: Full Time
Job Location: Bengaluru
Reporting Relationship: India Quality Head
Opportunities With: Our Clients

Key Responsibilities


  • Report to Head Quality and Compliance regarding day today activities of company’s Quality Control department.
  • Identify department staff requirement and recruit the employees for Quality Control.
  • Provide support to the manufacturing operation during the execution of commercial batches with in the stipulated timeline.
  • Ensure the investigation is closed on time and the quality trending is completed in stipulated timeline.
  • Ensure a disciplined work environment aligned to the Quality Culture and to provide expertise to subordinate colleagues in the proper performance of laboratory procedure.
  • Review and approve of method validation, method verification, cleaning validation, and qualification protocol and reports.
  • Review and approve SOPs, process validation protocols, deviations, change controls, lab investigations and other QMS documents related to Quality Control.
  • Ensure the compendia/supply driven changes are verified and completed on time to support the product supply.
  • Provide support to conducting the stability study of commercial product, site transfer project to the organization.
  • Ensure stability sample management and testing as per the procedures.
  • Evaluate trends for stability samples, water samples, and initiate corrective action and if applicable follow up and report on quality improvement system.
  • Responsible for the operation of all quality control laboratory in the company, including operation budget and resource management.
  • Participate and support in USFDA audits and other regulatory inspections.

Candidate Profile

Key Skills

  • Exhibited business acumen in understanding cross-functional processes, requirements, and relevant information flows, and translating gaps into solutions.
  • Demonstrated strategic, process-driven, analytical, and critical thinking.
  • Proven experiences in holding people accountable, developing cross-functional teams, and facilitating decision-making processes.
  • Strong organizational, interpersonal and communication skills.
  • Proven ability to lead, manage and motivate subordinates.
  • Demonstrated interpersonal savvy and relationship management/networking skills.
  • Strong ability to deal with ambiguity and manage through difficult situations.
  • Proven ability to manage multiple, complex projects at the same time.
  • Excellent ability to delegate and can effect change through others without direct involvement.
  • Strong written and oral communication skills.

Qualification & Experience

  • Master’s Degree in Science or Pharmacy
  • Minimum 20+ years of professional related experience in Formulation pharmaceutical manufacturing environment and at least 10-12 years in managing the laboratory function.
  • Experience in Pharmaceutical Manufacturing operations and controls change management processes, regulatory affairs, validation, leadership, influencing, and negotiation.
  • Strong understanding of GMP requirements and their application in a manufacturing environment.  Knowledge of international GMP requirements.

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