Director, Site QA Lead & Third Party QA Support - Coventry, RI
Trioptus Coventry, RI
- Expired: over a month ago. Applications are no longer accepted.
Title: Director, Site QA Lead & Third Party QA Support
Location: Coventry, RI (On site)
Provide strategic direction and input to all Quality activities at the Coventry site. Assure succession for key Quality roles for Rhodes Pharmaceuticals and support business activities and projects. Ensure quality activities at external contract development organizations and GMP commercial suppliers or contract manufacturers and the materials/finished product supplied by these firms meet all appropriate regulations and Purdue company and subsidiary requirements. Quality interfaces between the companies are data driven and serve to further improve the quality of the supplied material while maintaining a reliable supply chain.
Responsible for establishing the Quality Systems and procedures for the GMP development life cycle for third party development, clinical supply, and commercial manufacturing, packaging, testing and distribution of drug products.
Provide QA oversight of product development, submission batch manufacture, regulatory dossier development, validation activities and technology transfer, as needed ensuring compliance with current regulatory thinking and industry best practices, including risk-based scientific rationales for value-added validation.
- Provide strategic input relative to Coventry Quality activities for Rhodes Pharma. Interface with the business to define appropriate Quality programs to support business initiatives while maintaining key Quality and Compliance reputation and directives.
- Establish & maintain creative compliant Quality Systems for third party CMC product development activities for Rhodes Pharmaceutical, Avrio Health, Imbrium and Adlon and ensure their goals and timelines are met. Ensure compliance with Purdue policies and procedures, as well as industry best practices.
- Establish and maintain Quality oversight of third party commercial manufacturing and packaging activities for all Purdue subsidiaries. Manage the supplier qualification and auditing programs applying risk-based approaches to oversight.
- Lead due diligence activities for the Purdue Quality organization, as requested, to identify issues/investments needed to ensure compliance & allow appropriate valuation of assets under review. Provide project management of integration of any new assets in development where the ownership of activities passes to Purdue and those already commercialized and supplied by third parties to ensure on-time compliant deliverables.
- Develop the budget for operations under the responsibility of the role and ensure services are delivered within budget and on time.
- Work with internal departments including Supply Chain Management, Regulatory, PD&D, Pharmaceutical Development, R&D, and Legal to ensure the required infrastructure is in place for each supplier/contractor to produce quality product and/or service in a timely manner. Ensure the establishment of Quality Agreements for GMP Commercial and R&D suppliers of goods and services.
- Ensure an operational culture focused on partnership with Purdue suppliers/contractors to ensure free flow of information that will facilitate appropriate quality assurance and cGMP compliance decisions. Effectively apply risk analysis/mitigation in compliance decisions. Capture appropriate metrics and review them on a periodic basis for proactive identification of potential problems and improvement opportunities.
- Responsible for the oversight and hosting of FDA and other cGMP inspections associated with the Rhodes Pharma Coventry site activities and any other sites in relation to supplier activities.
- Provide opportunities for overall growth and development of staff to drive retention, material/ product quality improvement, and efficiency.
Education and Experience Requirements
BS required for external applicants and 15+ years minimum experience in a pharmaceutical technical operations/QA leadership role, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 10 years minimum experience or PhD with 8 years minimum experience. Minimum of 3 years of experience in providing QA oversight of suppliers/contract manufacturers.
Necessary Knowledge, Skills, and Abilities
- Strong technical understanding of manufacturing and packaging operations for pharmaceutical, OTC and dietary supplement products.
- Experience with solid dose, parenteral, non-sterile liquid and transdermal. Experience with biopharmaceutical products and/or medical devices is desirable.
- Understanding of international regulatory requirements.
- Experience in managing quality assurance for international contract manufacturers and strong working knowledge of all GxPs.
- ASQ certification as a Quality Auditor is preferred.
- Demonstrated experience with pharmaceutical clinical supply processes.
Manages a team of Quality Assurance professionals responsible for providing technical oversight of suppliers and contractor developers and manufacturers at multiple US and international locations.
- Consults with senior management and peers and refers to external literature to make sound decisions and recommendations.
- Proficient in use of root cause analysis and other problem-solving tools.
- Use of risk assessment/mitigation tools in decision making relative to product quality issues and compliance.
- Effectively manages/influences/negotiates cross functionally to accomplish goals and objectives; anticipating resource needs as part of long range strategic planning.
- Correlates daily tactics to deliver performance which drives the team toward broader strategic goals.
- Directly impacts quality standards for the company product portfolio.
- Interfaces with the suppliers/contractors to resolve non-conformance investigations which can impact product supply. In addition, the cost of implementing corrective and preventive actions required to address non-conformances may impact cost of goods, highlighting the need for pragmatic solutions.
- Forecasts, develops and obtains support for proposed budgets and controls expenditures vs. the budget.
- Will report to VP, Quality.
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