This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. This role is focused on documenting and communicating deviations and the findings to relevant stakeholders. This role will develop and maintain risk-mitigation strategies to mobilize company resources towards timely resolution of deviation or noncompliance issues. This role is responsible to track and report on open items that could be affecting product release to the market or the completion of other projects affecting progress based on pending items. This position is responsible for managing the investigation activities for the Ohio sterile manufacturing facilities and QC/Micro Laboratory. This work will need to be done while working collaboratively with all other functional business areas.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Lead deviation/investigation activities involving production batch records, and support release of product for shipment.
• Oversee Functional Areas and site QA investigations to ensure they are complete.
• Lead Investigator personnel and other SMEs to assure timely and quality oversight of documentation generated to support deviation management related to manufacturing/filling of sterile drug product.
• Partner with Production, Regulatory Affairs, Engineering, and QA Compliance to strategize and organize implementation of new technology, processes, and products.
• Lead on-site activities in investigating deviations, CAPAs, or other compliance issues associated with daily manufacturing operations.
• Identify and facilitate the resolution of any issues in conjunction with senior QA staff related to timely release of ARI products.
• Provide visibility to Senior Management for investigation reports requiring additional attention.
• Identify and facilitate improvements to increase efficiencies in systems, operations, and personnel as they relate to risk-based management activities and product release.
• Write and revise SOPs and other cGMP documentation.
• Able to identify and lead Continuous Improvement initiatives.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
• Manage day to day activities of Investigator staff across multiple areas; establish and maintain development plans, performance goals, training plans and productivity metrics; provide regular feedback to ensure staff is meeting workload and quality metrics.

• Effectively manage multiple tasks and work under pressure to meet deadlines.
• Build and maintain positive relationships throughout the organization.
• Position has responsibilities at multiple locations in central Ohio.

• Perform any other tasks/duties as assigned by management.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelors' Degree in Life Science or equivalent course of study, required. Master's degree, preferred.
• Minimum 5 years progressive experience in Pharmaceutical or similar FDA regulated environment.
• Minimum of 3 to 5 years management experience in a cGMP environment or a similar FDA regulated environment.
• Expertise across multiple areas including developing system requirements for cGMP compliance and release of cGMP production batches.
• Knowledge of MS Applications (Word, Excel, Outlook, PowerPoint, etc.).
• Proven record of exceptional people and program management skills.
• Knowledge of US regulations and established expertise in interpreting and applying to organization.
• Excellent organizational, interpersonal and communication skills (oral and written).
• Ability to work independently and deliver timely results.
• Ability to work off hours and weekends as needed.
• Ability to take feedback constructively and function in a team-oriented work environment.
• Ability to travel and work as needed at alternate sites.
• Knowledge of ICH-Q9 Risk-Based Deviation Management policy is preferred.
• Aseptic manufacturing, isolator technology and cleanroom experience, preferred.

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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