The Vice President, Global Quality Assurance is responsible for establishing, monitoring, maintaining, and evolving the Quality strategies of the Sentry Group to align with applicable regulatory agency requirements (e.g. FDA, DEA, USDA, US CBP, and EMA; National Association of Boards of Pharmacy (NABP); US states’ boards of pharmacy; current GxPs), as well as client needs. This position provides leadership, direction, and coordinates all Quality activities in accordance with the Group’s procedures, policies, goals, and objectives. As the Group continues to grow, the Vice President, Global Quality Assurance will build and lead a highly performing team of quality professionals to meet all current and future needs of the Group and its clients.
Essential Duties & Responsibilities:
The primary function of the Vice President, Global Quality Assurance is to build, monitor, and sustain compliant, audit-ready Quality Assurance/Quality Control departments. The Vice President, Global Quality Assurance leads the personnel at the group sites through the site Directors and is responsible for performance that meets expectations necessary to maintain regulatory compliance, drive growth, and client satisfaction.
Specific responsibilities include, but are not limited to:
- Develop and implement the management of Group and site-specific Quality Management Systems (QMS) meeting cGMP requirements including SOPs, client-specific procedures, and safety training programs.
- Ensure all Group employees and on-site service vendors are trained in (as applicable) cGMPs, Group SOPs, policies, Client-specific procedures, and safety programs.
- Provide oversight and advice for facility/equipment validation programs.
- Responsible for the quality aspects associated with materials management. Ensure that all Client products at the site are processed, stored, manufactured (labeling/packaging/kitting), and distributed in compliance with QMS, Quality Technical Agreements, cGMPs, and applicable laws and regulations.
- Responsible for oversight and management Quality functions such as complaint evaluation, internal and external investigations, the CAPA program, internal audits, vendor auditing/qualification, batch record review and release, data trending, etc.
- Responsible for management of Quality Change Controls.
- Oversee and direct the implementation and operation of a Quality Control laboratory providing sampling and stability testing including the selection and hiring of a Quality Control Manager.
- Assure metrics, goals, and priorities are implemented and within the QA and QC departments.
- Oversee and participate in on-site regulatory, Client, and third-party audits.
- Maintain a working knowledge of applicable laws, regulations, and NABP/VAWD requirements.
- Responsible for developing and directing the Group’s regulatory strategy, objectives, policies, and programs.
- Direct initiatives that accomplish continuous improvement, cost effectiveness, and enhanced efficiencies while maintaining compliance of processes and procedures.
- Oversee the Quality departments in regard to human resources including interviewing and selection, organizational development, and mentoring, coaching, counseling, and employee discipline, as required.
- Communicate to the President and Executive Vice President any critical cGMP and/or non-compliance issues in a timely manner.
- Be a contributing member of the leadership team and engage in business decision making from a Quality perspective.
- Facilitate interactions between QA/QC, Operations, and Business Development teams in order to help set and meet Clients’ quality requirements while maintaining compliance.
- Provides proactive guidance to the Business Development and Operations departments based on technical and regulatory knowledge to assure continuous compliance with applicable regulations.
- Identifies and assesses regulatory risks associated with regulatory changes and Clients’ requests for services.
- Coordinates with external GxP subject matter experts as needed to ensure the management team is fully informed of new GxP requirements and assesses the impact of regulatory changes on corporate policies.
- Other duties and responsibilities as assigned.
- Excellent leadership skills including the ability to lead projects with a broad scope, cross functional nature and ability to impact outside department while promoting teamwork between departments.
- Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
- Excellent communication skills with all levels of the organization and ability to develop rapport with other functional leaders within the Group to make decisions.
- Drives results through team leadership. This would include working with the team/individual to define specific goals and progress measuring tool.
- Strong problem solving, solutions orientation and presentation skills.
Education and/or Experience:
- BS or BA degree in life sciences, physical sciences, engineering, or related discipline.
- 8 years or more of quality management experience in pharmaceutical, medical device, or other related industries.
- In-depth knowledge of regulatory requirements for controlled storage and/or pharmaceutical manufacturing facility.
- Experience with regulatory inspectors (e.g., FDA, EMA, PMDA, notified bodies, etc.).
- Proven ability to work cross-functionally to achieve business outcomes.
- Experience in auditing/inspecting, data and document review, internal and external inspection.
- Experience and knowledge of international regulations governing pharmaceuticals with particular emphasis on EU Regulations.
- Sufficient knowledge of general pharmaceutical lab methods, techniques, and instrumentation to be able provide oversight and direction to laboratory personnel performing typical pharmaceutical stability analyses.
Location: Indianapolis, IN
Department: Quality Assurance
Schedule: Full Time, On-Site
Experience: 8 Years, Pharma, Lab
Travel Required: Some, Including International