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Civica Rx · 4 weeks ago

Site Head of Quality and Compliance

Petersburg, VA

Full-time

Onsite

Senior Level

7+ years exp

Civica Rx is a nonprofit organization focused on addressing the critical shortages of essential generic injectable drugs in U.S. healthcare. The Site Head of Quality and Compliance will lead the establishment of the Quality Management System and ensure compliance with FDA regulations for the manufacturing of sterile injectables.

Pharmaceutical

H1B Sponsor Likely

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

Qualification

Pharmaceutical manufacturingQuality Management SystemRegulatory complianceSterile injectablesAnalytical skillsLeadershipProblem SolvingCustomer ServiceDelegationBusiness AcumenDiversityEthicsProfessionalismSafetySecurityOral CommunicationWritten CommunicationTeamworkAdaptabilityStrategic Thinking

Required

Bachelor's degree in life science or engineering discipline

Minimum 7-10 years of pharmaceutical manufacturing / 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

Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness; applies risk-based decision making principles to ensure compliance while enabling operational effectiveness

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

Adaptability - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Monitors transition and evaluates results; Able to deal with frequent change, delays, or unexpected events

Delegation - Delegates work assignments; Gives authority to work independently; Sets expectations and monitors delegated activities

Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff and others; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Improves processes, products and services.; Continually works to improve supervisory skills

Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals; Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources

Diversity - Demonstrates knowledge of EEOC policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Supports affirmative action and respects diversity; Builds a diverse workforce

Ethics - Treats people with respect; Works with integrity and ethically; Upholds organizational values

Strategic Thinking - Understands organization's strengths and weaknesses; Analyzes market and competition; Adapts strategy to changing conditions

Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments; Looks for ways to improve and promote quality; Monitors own work to ensure quality

Safety and Security - Observes safety, environmental and security procedures; Reports potentially unsafe conditions

Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent

Preferred

Experience with facility start-ups, site licensure, and regulatory approval processes strongly preferred

Company

Civica Rx

Glassdoor3.2

Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.

Founded in 2018

Lehi, Utah, USA

51-200 employees

https://civicarx.org/

H1B Sponsorship

Civica Rx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (7)

2024 (2)

2022 (1)

2021 (2)