Director, Quality

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Job Description

Job Overview

Reporting to the Regional Director of Quality, the Director of Quality & Regulatory ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. The incumbent plays an integral role in developing PPS’s overall cGMP compliance strategy, and ensures execution of the day-to-day quality assurance and compliance related tasks performed by personnel within his/her reporting structure.

Reporting Structure

This site based position reports to the Regional Director of Quality

Direct reports: Compliance Manager, Quality Assurance Manager, Analytical Quality Control Manage, Quality Systems Manager, Microbiology Manager

Indirect reports: There are a total of 18 indirect on the teams above.

Experience

• B.A. or B.S. in scientific field and/or equivalent
• Minimum of Fifteen (15) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience.
• Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
• Strong/demonstrated knowledge of GMP regulations, guidance, and general compliance expectations.
• Experience with CMC regulatory filing requirements and activities.
• Knowledge of current trends pertaining to ICH and US regulatory inspections and expectations. Also desirable: EU regulatory knowledge
• Regulatory inspection hosting experience mandatory, with experience for with global jurisdictions preferred
• Must have experience using Microsoft Office suite (Word, Excel)
  
  

Primary Responsibility

• Direct oversight of the following functions:
• 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 documents applicable to PPS
• Oversee the internal audit program
• Ensure the timely resolution and investigation of product complaints
• Coordinate and review all Quality (Technical) Agreements prior to senior management approval
• Oversee and provide (where appropriate) regulatory filing technical support and documentation activities for both client and Piramal projects
• 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
  

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

Job Info

• Job Identification 5810
• Job Category Quality Assurance
• Posting Date 06/14/2024, 06:31 AM
• Job Schedule Full time
• Locations 1500 BULL LEA ROAD,, Lexington, KY, 40511, US