Director of Quality

Be the First to Apply 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 such as development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider and experience with various technologies enables us to serve innovator and generic companies worldwide. Job Title Director of Quality & Regulatory Affairs Job Description 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 bodies (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: Maintains decision making authority and maintenance of systems to release or reject API, intermediates, starting materials, raw materials, processing aids, packaging components, and labeling; oversees system to ensure materials are produced and tested consistently with applicable regulatory findings; ensures cleaning records, environmental monitoring records, calibration records, etc. are appropriately reviewed and approved by QA; oversees 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 and with the QA team to ensure timely completion of investigation, batch record reviews and batch releases to meet the site's monthly targets. Inspections and Audits: Assumes lead role in regulatory inspections and client audits, prepares responses to audit findings, directs implementation of corrective and preventative actions (CAPAs); leads Pursiding PPS-Sellersville's internal audit program, schedules audits, prepares reports, directs implementation of CAPAs; leads PPS-Sellersville's external audit program, schedules audits, prepares reports, monitors contractor/supplier implementation of CAPAs; participates in implementation of quality agreements with clients, contractors, and suppliers. Provides 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. Maintains perseverance to drive and sustain changes at the site, being resilient and flexible, 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 where people can perform to their best abilities. Drives cost control and cost reduction through strategic initiatives; responsible for developing and complying with the Quality budget. Investigations, Corrective Action/Preventative Action: Reviews and/or approves deviations, out-of-specification reports, formal investigations, complaint investigations; manages the CAPA program and related reports. Training: Responsible for overall employee training and skills assessment for the site; ensures the site is staffed with adequately experienced, trained and equipped quality management personnel; coaches, mentors staff on job activities and career development. Records and Reports: Ensures appropriate quality assurance review and approval for process validation, cleaning validation, analytical method validation, equipment/utilities qualification and stability; prepares reports related to equipment, processing, or testing as requested by the client; prepares, reviews, and/or approves Annual Product Reviews. Procedure Preparation, Review, and Approval: Prepares, edits, reviews, and/or approves Standard Operating Procedures administering the Quality System; ensures appropriate approval for all master production procedures, specifications, and analytical test methods; evaluates changes that may affect API quality and either approves or rejects proposed changes (Change Control). Regulatory Responsibilities: Works with Regulatory Affairs Manager to provide regulatory and CMC support for clients, including preparation of documents for USFDA submission (DMFs, CTDs, DTFS), maintaining existing submissions with annual updates, and coordinating responses to agency questions; maintains all necessary regulatory licenses for site operations. Key Competencies Highly motivated self-starter who 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 for preparation of CMCs, DMFs or CTDs. Knowledge of Lean Manufacturing, Six Sigma and team problem solving. Knowledge of other industry guidance documents (e.g., 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. Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline. Strong analytical skills and 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 a scientific or healthcare discipline or equivalent combination of education and related experience. 15+ years of pharmaceutical or biotechnology QA and regulatory experience, with demonstrated growth in responsibilities and expertise. 7+ years of 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. #J-18808-Ljbffr