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.
Manufacturing includes processing, packing, holding, labeling operations, testing, and quality unit operations.
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.
- Coordinate site hiring of the Quality Unit and collaborate with the site Operational team and General Manager in building a site team.
- Develop quality policies, goals, objectives, and executive reports.
- 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.
- 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.
- 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.
- 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.
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Technical Skills - Pursues training and development opportunities; Strives to continuously improve and build knowledge and skills.
- Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments; Maintains confidentiality.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.
- Written Communication - Writes clearly and informatively; Able to read and interpret written information.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Inspires respect and trust.
- 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.
Civica’s mission is to ensure that essential generic drugs are available and affordable to everyone. Civica’s vision is to become a model generic drug company by providing quality Food and Drug Administration-approved products. Civica’s foundational values of safety, quality, accessibility, affordability, and fairness drive the company’s efforts. Civica has been specifically designed to “do what is in the best interest of patients”. Building our first manufacturing facility is one part of fulfilling our mission in further ensuring supply of essential generic medicines.
We are seeking experienced individuals who have a passion for focusing on what’s in the best interest of patients to join the Civica team and mission.