Associate Director of Quality & Regulatory

Company: CTI Education Group
Location: Lexington
Posted on: February 22, 2021

Job Description:

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  • - Beginning of the main content section. Return to the home page Printable Format Job Description - Associate Director of Quality & Regulatory (200002TL) Job Description Associate Director of Quality & Regulatory - ( 200002TL ) Description Piramal PharmaSolutions is the Contract Development and Manufacturing arm of PiramalEnterprises Ltd., with operations across North America, Europe and Asia. We area global leader in integrated solutions and offer a unique platform of servicesacross the drug lifecycle - from drug discovery and development to commercialmanufacturing of drug substances and drug products. Our capability as anintegrated service provider & experience with various technologies enableus to serve innovator and generic companies worldwide. We are currently seeking an AssociateDirector of Quality & Regulatory for our pharmaceutical manufacturingfacility in Lexington, KY. POSITION SUMMARY Reporting to the Director of Quality, the Associate Director of Quality &Regulatory ensures compliance with regulationsgoverning the manufacturing, testing, warehousing, and distribution of pharmaceuticaldrug products.The incumbent plays anintegral role in developing PPS's overall cGMP compliance strategy, and ensuresexecution of the day-to-day quality assurance and compliance related tasks performedby personnel within his/her reporting structure. PRIMARYRESPONSIBILITIES
    • Direct oversight of the following functions:
      • Validation
      • Quality Assurance (including Investigations, Material Release, and QA-Operations)
      • Compliance / Document Systems
      • Quality Systems / Regulatory
      • Direct oversight of Quality systems, ensures the activities are performed and closed in a timely manner, specifically:
        • Deviations (Events)
        • CAPA
        • Change Control
        • Review and approve controlled documents requiring QA approval signature, including:
          • Client Audit Observations
          • Internal Audit Reports/Responses
          • Executed cGMP Batch Records
          • Master Batch Production Records
          • Process Simulation and Process Validation Protocols
          • Standard Operating Procedures
          • Material Specifications
          • Test Methods
          • Stability Protocols
          • Qualification Protocols
          • Review and approve activities conducted by outside vendors that directly impact the quality of products manufactured at PPS, including:
            • Calibrations
            • HEPA Certifications
            • Perform batch disposition activities -- Coordinate the implementation and maintenance of regulatory documentsapplicable to PPS
              • Coordinate and review all Quality (Technical) Agreements prior to senior management approval -- Oversee the internal audit program
                • Oversee and provide (where appropriate) regulatory filing technical support and documentation activities for both client and Piramal projects -- Ensure the timely resolution and investigation of product complaints
                  • Oversee PPS Supplier Quality Management program
                  • Participate in client project meetings as well as PPS project meetings
                    • Periodic "stand-in" stand-in for Director of Quality duties, as designated
                    • Coordinates daily and monthly staffing schedules, capacity planning and cross-training efforts
                    • Assists senior QA management with identifying staffing needs and contributes to hiring decisions. WORKENVIRONMENT
                      • Ability to work in a high demand office and manufacturing setting with extended time with "on the floor" activities (in the lab, manufacturing core, and warehouse settings).
                      • Position may require extended hours including evenings and weekends, travel to multiple work sites and occasional out-of-town travel.
                      • Ability to work in a safe manner with materials of potential high potency and/or toxicity in a limited capacity.
                      • Ability to cross-train in identified quality unit activities outside of the QA department in a supporting capacity. Piramal PharmaSolutions provides equal employment opportunities to all employees andapplicants for employment and prohibits discrimination and harassment of anytype without regard to race, color, religion, age, sex, national origin,disability status, genetics, protected veteran status, sexual orientation,gender identity or expression, or any other characteristic protected byfederal, state or local laws. This policyapplies to all terms and conditions of employment, including recruiting,hiring, placement, promotion, termination, layoff, recall, transfer, leaves ofabsence, compensation and training.
                        Qualifications QUALIFICATIONS -- B.A. or B.S. in scientific field and/or equivalent -- Minimum of ten (10) years' progressive experience in a regulated cGMPindustry is required, with five (5) years' management experience. -- Must have e xperience workingwithin a GMP parenteral/sterile manufacturing environment, contractmanufacturing a plus -- Strong/demonstratedknowledge of GMP regulations, guidance, and general compliance expectations. -- Experience with CMC regulatory filing requirements andactivities a plus. -- Knowledge of current trends pertaining to ICH and US regulatoryinspections and expectations. Also desirable: EU regulatory knowledge -- Regulatory inspection hosting experience mandatory, with experience forwith global jurisdictions preferred -- Must have experience using Microsoft Office suite (Word, Excel) Primary Location : United States-Kentucky-Lexington Work Locations : Lexington 1500 BULL LEA ROAD, SUITE 250 Lexington 40511 Job : Quality Assurance Organization : Pharma Solutions Day Job Job Posting : 21-Dec-2020, 4:50:55 PM

Keywords: CTI Education Group, Huntsville , Associate Director of Quality & Regulatory, Professions , Lexington, Alabama