HomeHead/VP/CEO/President/GMQuality Head - Drug Substance | Biocon Ltd | Bengaluru

Quality Head – Drug Substance | Biocon Ltd | Bengaluru


Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.

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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.

We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.

Position: Quality Head – Drug Substance

Location: Bangalore, Karnataka, India

Job Description:

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high-quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization.


  • Accountable for product quality and compliance of operations, per scope – Accountable for defining, setting up, executing, and continuously improving any related activity, including organizational and human aspects.

Role/Job Description

  • Lead and drive all Operational QA activities for the allocated perimeter, ensuring products always manufactured have the expected level of quality while maintaining compliance
  • Ensure all-time inspection readiness of operations per scope, including preparation to regulatory inspections
  • Foster a doing the right things right-first-time culture across operations, per scope
  • Implement BBIL Quality management system and governance, propose and implement improvements
  • Drive quality management reviews
  • Ensure consistency, standardization, efficiency, and cost-effectiveness of approaches while always maintaining compliance with regulations and clients’ expectations
  • Define, implement, monitor quality strategy and plan for the allocated perimeter, defining appropriate metrics, relentlessly seeking, and implementing best practices or any improvements
  • Ensure proper organizational design to best meet customers’ needs
  • Lead, manage, develop, and coach the team, fostering the right behaviors and mindset
  • Closely interacts with all business functions to ensure effective contribution to BBIL ambition

Technical / Functional Skills

  • Must have experience in Biologic DS manufacturing processes
  • Extensive knowledge of worldwide applicable Quality regulations (US, EU, Brazil, etc.)
  • Good understanding of Lean principles (Green Belt certification is a “plus”)


QualificationM.Sc./Pharm.D or equivalent

Experience: Min. 15 years of experience in multinational pharma/biopharma companies, covering site Operations/Quality roles with significant international and biologic drug substance manufacturing exposure

Salary: Negotiable

careers@biocon.com, human.resources@biocon.com, amrita.ganguly@biocon.com

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