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.
The Director, Quality & Regulatory Affairs 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 Operations is responsible for the quality unit at the site and for oversight of all quality related activities at the site. The site quality head 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 the Quality Assurance, Quality Control, Stability and related site quality activities, including commercial and development products.
Release or reject API: Maintain decision making authority and maintenance of systems to release or reject API, intermediates, starting materials, raw materials, processing aids, packaging components, and labeling; Oversee system to ensure materials are produced and tested in a manner consistent with the applicable regulatory findings; 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 Batches: Works with the QC team to ensure the availability of materials necessary to meet the site’s targeted number of API batch releases.
Works with the QA team to ensure the timely completion of investigation, batch record reviews and batch releases to meet the site’s monthly targeted batch releases.
Inspections and Audits: Assume lead role in regulatory inspections and client audits, prepare responses to audit findings, direct implementation of corrective and preventative actions (CAPAs); lead PPS-Sellersville’s internal audit program, schedule audits, prepare reports, direct implementation of CAPAs; lead PPS-Sellersville’s external audit program, schedule audits, prepare reports, monitor contractor/supplier implementation of CAPAs; participate in implementation 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.
Constantly communicates 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 Action (CAPA) program and other reports as necessary.
Training: Responsible for the overall 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 intermediates or APIs; evaluate changes that may affect API quality and either approve or reject proposed changes (Change Control).
Regulatory Responsibilities: Work with Regulatory Affairs Manager to provide Regulatory and CMC support for clients including the preparation of documents for submission to USFDA, including Drug Master Files and Common Technical Documents; maintaining existing submissions with annual updates; and coordinating the preparation of responses to agency questions regarding these applications. Maintain all necessary regulatory licenses for site to continue operations.
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/or ICH Q7).
Knowledge of Drug Regulatory requirements, specifically as relates to preparation of CMCs, DMFs or CTDs.
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 degree strongly preferred. Education Preferred MS or Ph.D. in scientific or healthcare discipline or equivalent combination of education and related experience.
15+ years’ Pharmaceutical or Biotechnology QA and Regulatory 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
