Director, Quality
The Director, Quality is a strategic partner to the management team at Piramal Pharma Solutions – Lexington (PPS). This Senior Level role must be able to articulate and achieve clear objectives as well as sound and effective processes. This role is responsible for leading and supervising quality strategy and execution within the company to direct good practices reducing risks on development of new technologies and collaborative projects within the organizational portfolio. This individual will work closely with the leadership team to foster, direct, and continually improve quality throughout the organization as well as cost and time factors consistent with PPS business objectives. Coverage of responsibility includes Quality Assurance, Document Systems, Quality Control, Microbiology, and Validation groups.
Primary Responsibilities
•Ensure compliance with applicable internal and external regulations, standards, policies, and procedures related to quality and regulatory status and performance of company operations, processes, and products.
•Represent company as the primary liaison with involved external regulatory and standards bodies (e.g. Food and Drug Administration-FDA). When necessary, adjudicate issues with product submissions, product performance, compliance concerns, and prevailing/impending regulatory requirements.
•Represent company as the primary liaison with involved client quality audits. When necessary, adjudicate issues with client and PPS quality systems. Represent PPS Quality Assurance department in project meetings.
•Responsibility for the identification and escalation of emerging company compliance trends within organization; assist in developing strategies to mitigate or remediate trends.
•Provide updates and recommendations to company quality council and company senior management staff with regard to status of such quality and compliance strategies, projects, and goals as related to cross-functional business objectives.
•Work closely with the leadership team to foster and direct quality throughout the organization continually improving quality. Lead the quality culture of PPS by effectively utilizing departmental resources.
•Responsible for development and execution of quality strategies and objectives within the organization.
•Focus management on the appropriate metrics and actions based on those metrics across the organization assuring effective tracking of operational performance.
•Ensure internal audit program is adequately defined and followed (inclusive of comprehensive CAPA development, approval, and execution) in a timely and effective manner.
•Conduct external audits as required.
•Ensure product is released in a timely manner in compliance with company procedures and regulatory requirements.
•Define and approve departmental budget and capital expenditures.
•Exercise independent action in hiring and firing personnel within established company policy and procedures.
•Lead and mentor quality assurance and document system staff.
•Ensure PPS document control is within regulatory and company policies and procedures.
•Attendance of industry conferences to stay informed of current industry trends and expectations is required.
•Continually seek industry recognized certifications such as CQA, CPGP, or RAPS.
Requirements:
Qualifications
•Bachelor of Science Degree in a related field, advanced degree preferred
•A minimum of ten years' experience in pharmaceuticals
•Extensive experience in Aseptic/Parenteral pharmaceuticals is required
•FDA auditing experience mandatory.
•Background in global QS and international management preferred
Why Piramal? Our People and Technology
Working at Piramal will provide you with the opportunity to work in a brand new, state of the art laboratory surrounded by talented, hardworking, team-oriented professionals.
Submit your application and resume and we will get back with you shortly.
