Our client, a leading Life Sciences company, is hiring a Quality Investigations Supervisor.

Work Location: Wake County, North Carolina

Summary:

The Quality Investigations Supervisor is responsible for overseeing the personnel and processes associated with developing, establishing and sustaining the site’s Quality Compliance. This individual will supervise teams supporting exception/deviation and compliant investigations and the associated CAPA process. The Quality Investigations Supervisor is responsible for driving compliance-based programs to ensure the Quality Department supports internal and external customer requirements. Internal customer groups will rely heavily on the incumbent to make data driven and highly technical decisions in a timely manner and provide the support necessary to carry out those decisions. The Quality Investigations Supervisor is a key role in creating and maintaining a culture of quality, compliance, safety, service and cost initiatives.

Responsibilities:

• Responsible for direct supervision of quality teams for Exception and Customer Complaint Investigations, and management of the CAPA process.
• Strong leadership skills with the ability to prioritize, multitask and work efficiently in a dynamic, ever changing manufacturing environment.
• Manage multiple team groups which are composed of various job levels that support production activities for the filling, formulation, and packaging groups.
• Support data integrity requirements through data review and investigations; including the coordination and assignment of required actions and action owners.
• Strong mentoring skills and a track record of developing subordinates through developing goals and delivering effective performance reviews.
• Identify quality issues and, in conjunction with Site Head of Quality, provide recommendations for the implementation of corrective and preventative actions.
• Exceptional cross-functional communication with multiple individuals, departments, contractors, and auditors, along with strong organizational skills.
• A strong, balanced knowledge of quality, laboratory, manufacturing and validation processes.
• Knowledge of cGMP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.
• Knowledge of facilities, utilities, and manufacturing processes, including aseptic and terminal sterilization processes.
• Working knowledge of green belt and lean tools.
• Knowledge of regulatory agency inspections and vendor audits.
• Able to respond / react with appropriate urgency / professionalism and make decisions under pressure.
• Support the goals and initiatives tied to the Quality Plan and department goals.
• Develop and present presentations and instructor-led investigator training to individuals and groups.
• Evaluate current systems and process to determine the necessary upgrades, additional technology and improve as needed.
• Manage group metrics for the primary monitoring functions of the facility and report during the scheduled QMR meetings.
• Write, review and / or approve departmental documents, procedures, reports and investigations
• Support document approval for change requests, risk assessments, reports, test plans / technical transfers, investigative testing and procedures as needed.
• Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards)
• Performs other duties as assigned by management.

Department Specific / Non-Essential Functions:

• Work safely in accordance with regulations, standards and procedures and in a manner that eliminates unreasonable risk to personal health, others and the working / production environment.
• Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and / or environmental risk. Report all safety and/or environmental incidents to management immediately.
• Enforce EHS procedures and respond to EHS concerns within his/her area of operational responsibility. Perform incident investigations and follow through regarding corrective actions.
• Performs other duties as assigned by management.

Qualifications:

• BA/BS Degree in chemistry, biology, microbiology or life sciences or related engineering field required. Masters Degree preferred.
• Minimum 10 years experience in an FDA regulated pharmaceutical industry required. Knowledge of terminal sterilization process preferred.
• Minimum 5 years previous supervisory experience, showing ability to manage and drive change is required. Must be able to operate with minimal direction and be a self-starter.
• Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements required.
• Demonstrated auditing and corrective action proficiency, including successfully assessing and determining the impact of current and potential regulatory compliance issues, are required.
• Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment and excellent problem solving and decision making skills are required.
• Prior experience with electronic Quality Management Systems, and proficient computer skills are required.
• Professional and clear communication and strong interpersonal skills are required.
• The ability build relationships with other departments and to drive projects with multiple functional groups without direct reporting authority is required
• Statistical Analysis capability is strongly preferred
• Certifications such as ASQ, Six Sigma Greenbelt, etc. are preferred
• Ability to lift up to 35 lbs. without assistance.
• Ability to go up and down steps such as staircase or ladder.
• Ability to aseptically gown for production investigations
• Ability to read, comprehend, and interpret written procedures, batch records, and regulatory guidelines accurately and capacity to retain and apply knowledge consistently.
• Capacity to analyze data and identify discrepancies or trends that may impact product quality or compliance.
• Skill to apply logical reasoning and sound judgment when making quality related decisions.
• Ability to prioritize multiple tasks and manage time effectively to meet investigation timelines.
• Capacity to maintain attention to detail during extended periods of document review.
• Ability to communicate clearly and effectively in both written and verbal formats for documentation and cross-functional collaboration.
• Skill to evaluate risk and make decisions based on established quality standards and regulatory requirements.
• Ability to adapt to changing priorities and regulatory expectations while maintaining compliance.
• Ability to work independently and as part of a team to achieve quality objectives.

Published Category: Quality & Validation