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Quality Assurance Validation Manager
2 months ago
Company Overview:
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a prominent entity in the exploration of novel molecules, including New Chemical Entities (NCEs) and New Biological Entities (NBEs). With a robust generics business in the U.S. and aspirations to enter the innovative market, Glenmark is also engaged in marketing APIs to both regulated and semi-regulated markets. The company boasts a workforce of over 10,000 across more than 60 countries, supported by twelve manufacturing sites and five R&D centers globally.
Position Overview:
The Quality Assurance Validation Manager plays a pivotal role in steering the validation and qualification initiatives within the organization. This position is integral to ensuring compliance with corporate standards and regulatory frameworks, overseeing the validation processes for facilities, utilities, equipment, computer systems, and cleaning protocols. The role also encompasses support for facility start-up activities, technical transfers, and routine operations across Laboratories, Manufacturing, Maintenance, and Warehouse functions.
Key Responsibilities:
- Develop and manage the Revenue and Capex Budget, ensuring financial discipline in resource allocation while establishing top-tier quality processes and systems.
- Oversee quality system controls to mitigate critical and major market complaints.
- Implement strategies to minimize waste and enhance efficiency in the analysis process.
- Administer the validation system from a Quality Assurance perspective, ensuring alignment with quality and compliance objectives.
- Serve as the Subject Matter Expert (SME) for quality and validation in Change Controls supporting GMP/GLP systems.
- Ensure the implementation of necessary Standard Operating Procedures (SOPs) to facilitate internal and external validation programs.
- Provide quality oversight and approval for software, equipment, and facility qualifications, including IQ/OQ/PQ protocols and reports.
- Ensure adherence to the Site Validation Master Plan and Computer System Validation Master Plan at the site level.
- Monitor and approve internal and external process characterization project plans and protocols.
- Report on validation and qualification quality issues and trends to management.
- Guide and mentor staff on qualification and validation matters.
- Review executed calibrations and preventive maintenance plans, along with updates to calibration/PM programs.
- Revise SOPs to ensure consistency and compliance with regulatory standards.
- Oversee analytical laboratories in terms of instrument qualifications.
- Provide training to team members to achieve established goals.
- Support regulatory inspections conducted by FDA and international regulatory bodies.
- Engage in continuous improvement initiatives within quality systems by analyzing trends in key performance indicators, audits, and stakeholder feedback.
- Participate in cross-functional risk assessments and process parameter classifications.
- Review and provide expertise on Validation lifecycle documentation, including Process Design Documents and Master Plans.
- Support quality assurance for process, cleaning, shipping, computer system, equipment, and instrument qualification activities.
- Contribute to interdepartmental project teams to achieve company milestones.
- Stay informed on industry trends and technologies to enhance Quality Operations initiatives.
- Ensure compliance with current U.S. and EU cGMP regulations and industry standards.
- Apply risk-based methodologies in overseeing validation efforts and Computer System Validation activities.
Qualifications:
- A Bachelor's degree in Science, Engineering, or related fields is required.
- 6-10 years of experience in Quality Assurance or Design Assurance within the Pharmaceutical, Biotech, or medical device sectors, or related engineering disciplines.
- Advanced degrees may be considered to reduce the required experience.
Knowledge and Skills:
- Comprehensive understanding of quality tools, including CGMP, Validations, Regulatory guidelines, and Internal auditing.
- Strong grasp of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (QDP).
- Proficiency in Microsoft Office Suite, particularly Word and Excel, with strong documentation capabilities.
- Experience with statistical techniques and sampling plans is desirable.
- Ability to work independently and collaboratively on multiple projects while adapting to changing priorities.
- Excellent written and verbal communication skills, along with strong interpersonal abilities.
- Certification as a Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) is highly regarded.
