Director of Quality

1 week ago

Lexington, United States Piramal Pharma Solutions Full time

Piramal Pharma Solutions is a leading global CDMO of advanced drug development and manufacturing solutions to the pharmaceutical industry.


Reporting to the Regional Director of Quality, the Director of Quality & Regulatory ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. The incumbent plays an integral role in developing PPS’s overall cGMP compliance strategy, and ensures execution of the day-to-day quality assurance and compliance related tasks performed by personnel within his/her reporting structure.



Role

  • Direct oversight of the following functions:
  • Quality Assurance (including Investigations, Material Release, and QA-Operations)
  • Compliance / Document Systems
  • Quality Systems / Regulatory
  • Direct oversight of Quality systems, ensures the activities are performed and closed in a timely manner, specifically:
  • Deviations (Events)
  • CAPA
  • Change Control
  • Review and approve controlled documents requiring QA approval signature, including:
  • Client Audit Observations
  • Internal Audit Reports/Responses
  • Executed cGMP Batch Records
  • Master Batch Production Records
  • Process Simulation and Process Validation Protocols
  • Standard Operating Procedures
  • Material Specifications
  • Test Methods
  • Stability Protocols
  • Qualification Protocols
  • Review and approve activities conducted by outside vendors that directly impact the quality of products manufactured at PPS, including:
  • Calibrations
  • HEPA Certifications
  • Perform batch disposition activities

Coordinate the implementation and maintenance of regulatory documents applicable to PPS

  • Coordinate and review all Quality (Technical) Agreements prior to senior management approval

Oversee the internal audit program

  • Oversee and provide (where appropriate) regulatory filing technical support and documentation activities for both client and Piramal projects

Ensure the timely resolution and investigation of product complaints

  • Oversee PPS Supplier Quality Management program
  • Participate in client project meetings as well as PPS project meetings


  • Periodic “stand-in” stand-in for Director of Quality duties, as designated
  • Coordinates daily and monthly staffing schedules, capacity planning and cross-training efforts
  • Assists senior QA management with identifying staffing needs and contributes to hiring decisions



Requirements


  • Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
  • Strong/demonstrated knowledge of GMP regulations, guidance, and general compliance expectations.
  • Experience with CMC regulatory filing requirements and activities.
  • Knowledge of current trends pertaining to ICH and US regulatory inspections and expectations. Also desirable: EU regulatory knowledge
  • Regulatory inspection hosting experience mandatory, with experience for with global jurisdictions preferred

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