Site Head Quality and Compliance
Establishing and building the site team and infrastructure leading to the qualification and FDA approval of Civica’s fill finish manufacturing site for essential generic sterile injectable medicines. Responsibilities of the position includes, establishing and maintaining the Quality and Compliance policies, procedures, systems and oversight of the building and qualification of the manufacturing facility and ultimately the manufacturing, testing, packaging and release of quality essential medicines in accordance with Civica and U.S, Food & Drug Administration (FDA) regulations and expectations.
The Site Head of Quality and Compliance is responsible for the site Quality Management System, Quality Assurance and Quality Operations, and will be required to lead, develop and support compliance strategies and plans that meet CGMP, Drug Enforcement Administration (DEA) and all relevant governmental regulations and requirements applicable to the manufacture and distribution of human prescription drugs and devices. The Site Head of Quality must be able to 1) self-manage and work effectively with internal parties, external stakeholders, suppliers, and governmental agencies with very little direct oversight, 2) be responsible for establishing systems and assessing operations and identifying, prioritizing, and implementing actions to continuously improve operations and systems, and, 3) report directly to the Civica, Chief Quality & Regulatory Affairs Officer with a dotted line reporting relationship to the Site Vice President and General Manager.
Essential Duties and Responsibilities
- Build and lead a high performing site Quality & Compliance team.
- Establish and implement the site Quality Management System, Quality Control Unit and Quality Assurance processes and procedures.
- Engage and collaborate on all site matters with the Site leadership staff under the direction of the Site Vice President and General Manager.
- Build and lead systems, processes and procedures that meet or exceed local, state and federal regulatory agency and CGMP requirements and regulations in the operation of the Civica fill finish manufacturing facility.
- Interpret CGMP regulatory requirements and provide guidance for effective compliance, as well as providing support for programs and projects leading to the successful approval of a new sterile fill finish manufacturing facility.
- Develop quality policies, goals, objectives, and executive reports.
- Coordinate site hiring of the Quality Unit and collaborate with the site Operational team and General Manager in building a site team.
- Serve as the primary contact for any external or internal audit or regulatory inspection of the Civica manufacturing facility, with responsibility to oversee and/or prepare appropriate documented responses and implement associated corrective action plans. ·
- Provide technical guidance and facilitate problem-solving methodologies regarding quality-related issues.
- Lead multi-departmental teams to implement the quality strategies with respect to the collection, documentation, analysis, and reporting of quality data, key driver goals and Quality Indicators to drive corrective and preventive actions.
- Review complaint reporting and trend analysis to monitor field activity, to formulate corrective action feedback with appropriate site team members.
- Conduct investigations of non-conformance or unplanned events and undesirable trends affecting the quality of products in distribution, performing root cause analysis, and developing and implementing corrective and preventive actions.
- Escalate, investigate and manage events leading to product recalls, hold notifications, stop-shipments, etc. according to Civica policies and procedures.
- Provide training and guidance to ensure compliance with GMP Regulatory Requirements and Guidance, Standard Operating Procedures (SOPs), Departmental Operating Instructions, protocols and other governing documentation by Operations and Quality personnel.
- Lead site strategies and coordinate plans for facility qualification and regulatory approval.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Bachelor’s degree in life science or engineering discipline.
- Minimum 7-10 years of pharmaceutical manufacturing and quality operations in a leadership or managerial role.
- Ability to independently perform work of a broad nature with general direction and concurrence from senior management.
- Proven track record and experience in interfacing with regulatory bodies and regulatory agency inspections.
- Broad knowledge of sterile injectables manufacturing processes.
- Ability to effectively manage time and multiple task assignments as well as managing team assignments and direction.
- Supports a strong culture of accountability and inclusion and seeks to develop team capabilities as well as foster personal growth.