Director of Quality

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 feedback from team members and follows through on commitments.
• Creates a work environment in which people are able to perform to the best of their abilities.
• Through various strategic initiatives drive cost control and cost reduction. Responsible for working to develop and comply with the Quality budget.
• Investigations, Corrective Action/Preventative Action: Review and/or approve deviations, out-of-specification reports, formal investigations, complaint investigations, Corrective Action/Preventative Actions (CAPAs) and other reports as necessary.
• Training: Responsible for the overall Quality employee training and skills assessment for the site. Ensures the site is supported by sufficient adequately experienced, trained and equipped quality management and staff to control and assure the purity, efficacy, quality and strength of product manufactured at the site. Coaches, councils and mentors staff on issues relating to job activities and career development.
• Records and Reports: Ensure appropriate level of quality assurance review and approval for the following protocols and associated reports: process validation, cleaning validation, analytical method validation, equipment/utilities qualification and stability; prepare reports related to equipment, processing, or testing, as requested by the client; prepare, review, and/or approve Annual Product Reviews.
• Procedure preparation, review, and approval: Prepare, edit, review, and/or approve Standard Operation Procedures administering the Quality System. Ensure appropriate level of quality assurance review and approval for all master production procedures, specifications, and analytical test methods. Ensure appropriate level of quality assurance review and approval for all procedures affecting the quality of Finished Products.. Evaluate changes that may affect Finished Product quality and either approve or reject proposed changes (Change Control).

Key competencies:

• Highly motivated self-starter that can work, and lead, with minimal supervision.
• Demonstrated ability to identify improvement areas and implement solutions to streamline process, communication, training and consistency.
• Extensive knowledge of GMP requirements (21CFR Part 211, and Eudralex Volume 4).
• Knowledge of Lean Manufacturing, Six Sigma and team problem solving.
• Knowledge of other industry guidance documents (such as ISPE Bulk Pharmaceutical Guide, GAMP 5).
• Thorough knowledge of, and capability within, various Quality Management Systems.
• Proven change management and leadership skills.
• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines

Qualifications

• Bachelor’s degree in the physical sciences or engineering; advanced scientific or healthcare discpline degree strongly preferred
• 15 years’ Pharmaceutical or Biotechnology QA and QC experience, with demonstrated growth in responsibilities and expertise.
• 7 years’ experience managing all aspects of a Quality department and function.
• Significant work experience in a CMO and drug development environment.
• Demonstrated knowledge and experience in supporting a team and Quality practices in a high-growth environment.
• Detailed knowledge of chemistry and manufacturing controls