Associate Director, Quality Control

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Associate Director, Quality Control

Job Description

The Director, Quality will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality is responsible for the quality unit and oversight of all quality related activities at the site. The Director of Quality is responsible to ensure that the systems, procedures and practices at the site comply with Piramal policies and the requirements of all major regulatory body agencies (e.g. FDA/Health Canada/EMA, etc).

Director, Quality

Job Description

The Director, Quality will maintain Sellersville Quality procedures and systems to ensure regulatory compliance. The incumbent will be an integral member of the Senior Leadership Team. The Director of Quality is responsible for the quality unit and oversight of all quality related activities at the site. The Director of Quality is responsible to ensure that the systems, procedures and practices at the site comply with Piramal policies and the requirements of all major regulatory body agencies (e.g. FDA/Health Canada/EMA, etc).

Key accountabilities: 

• Management and Leadership: Leads Manufacturing Quality Assurance, Quality Systems and Compliance, Quality Control, Stability and related site quality activities, including commercial and development products.
• Release or reject Raw Materials/Packaging/Labeling Components: Maintain decision making authority and maintenance of systems to release or reject raw materials (including Active Pharmaceutical Ingredients (API) packaging components, and labeling. Oversee system to ensure materials are produced and tested in a manner consistent with the applicable regulatory filings and internal procedures. Ensure that ancillary documentation including cleaning records, environmental monitoring records, calibration records, etc. are appropriately reviewed and approved by QA. Oversee system for preparing Certificates of Analysis, Certificates of Conformance, Summaries of Test Results, BSE/TSE Certification, and Approved Labelling, as required by client.
• Release or reject Finished Product Batches:  Works with the QC team to ensure the availability of materials necessary to meet the site’s monthly production schedule f finished product batch releases.  Works with the QA team to ensure the timely completion of investigations, batch record reviews and batch releases to meet the site’s monthly targeted batch releases.
• Inspections and Audits:  Assume lead role in regulatory inspections.Lead or delegate hosting responsibilities to appropriate competent individual in support of prospective and active client audits Facilitate the preparation of  responses to audit findings, direct implementation of corrective and preventative actions (CAPAs). Oversee PPS-Sellersville’s internal audit programschedule audits which includesreport preparation, direct implementation of CAPAs. Oversee PPS-Sellersville’s external audit program which includes  audit coordinaiton, report preparation, monitor contractor/supplier implementation of CAPAs. Overseeimplementation of quality agreements with clients, contractors, and suppliers.
• Provide clear direction to achieve business goals, creating an environment that fosters team commitment and employee engagement such that revenue and expenditure targets are consistently met.
• Maintain the perseverance to drive and sustain the changes that occur at the site, while being resilient and flexible, and inspiring and motivating the team.
• Consistent communication to the team, is open to opinions and feed