Job Title: Vice President, External Manufacturing and Supply Quality
Job Number: 30538
Location: Lexington, MA
Reporting to the General Manager of the U.S with dotted line to Corporate Quality and Supply Chain and Distribution leadership, The Vice President, External Manufacturing and Supply Chain Quality, defines and shapes the Quality strategy for the external manufacturing partners, to ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products. In addition, this role is responsible for the US Supply Chain and Distribution Quality organization to ensure In Market quality and distribution practices are compliant to the regulations in the US, as well as ensuring adequate control exists in the product distributed in the US after disposition occurs.
- Support the development, direction, and execution of the Quality Strategy for the External Manufacturing Organization, Supply Chain and Distribution and corresponding commercial organizations in the US.
- Provides leadership direction for a multi-functional group of internal and consulting quality professionals, aligned with company culture that recognizes market practices and regulatory trends to achieve a uniform Quality strategy.
- With a focus on corporate goals, ensure that the Company’s quality system is designed, implemented and maintained in accordance with FDA Quality System Regulation, ISO, and the GMPs, and other applicable standards or regulations.
- Responsible for progressing the suitability and effectiveness of the quality management system and GMP compliance through leading the required quality management reviews.
- Deploys Quality Risk Management Techniques for quality oversight and problem resolution to mitigate unacceptable risk in conjunction with Thea Manufacturing/Supply management and Quality.
- Manage/support the resolution of quality and technical problems within the organization in alignment with global standards.
- Support audits and Health Authority inspections for the functional areas or sites as necessary, including the assistance in the generation of HA responses and CAPAs. Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines
- Assure appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures.
- Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS (Quality Management System).
- Coordinates and/or provides SME (Subject Matter Expert) input to for Thea Policies, Directives, SOPs related to quality compliance when required.
- Direct and control activities in the following functions: product release, complaint administration, internal auditing and supplier management.
- Successfully develop and deliver Regulatory and Quality Assurance training.
- Collect data from internal and external audits and report metrics and trends in order to drive improvements to process and services within relevant organizations.
- Develop a high-performance culture within the organization. Coaches, leads and mentors direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs. Prepare and manage organizational Quality Budget.
- BS Degree in a scientific discipline or equivalent.
- Minimum of 10 years relevant experience in a regulated industry, pharmaceutical, life sciences technology or medical device company.
- Excellent working knowledge of drug development process and knowledge of FDA regulatory requirements.
- Experience with development stage regulatory compliance and quality requirements.
- Develop and drive end-to-end product quality from non-clinical development through the life of the program, including commercial launch, in alignment with commercial business drivers and process development capabilities.
- Provide and represent QA’s perspective and expertise on development teams.
- Identify key product quality issues and risks. Raise full awareness of the risks, including weak signals and potential blind spots and escalate as appropriate.
- Interpret and apply applicable Health Authority regulations and guidance.
- Support product regulatory filings by driving clarity and consistency with specifications and CQAs. Support product transition from clinical to commercial, new product introductions and tech transfers across the network.
- Ensure alignment of product changes and collaborate with key colleagues to develop bundling strategies that maintain supply while improving product robustness.