Job Summary

The Compliance Manager is responsible for plant quality compliance initiatives and programs. They are the site liaison for Global and Regional quality programs, e.g, eQMS. The position is responsible for maintaining the investigative system and providing direction on the process, including the proper assignment of risk, identifying all the factors causing an event, and providing direction to staff on root cause analysis. Proactively leads quality system enhancement projects to decrease the likelihood of action resulting from a regulatory inspection. Works in partnership with manufacturing operations, tech transfer, quality control and assurance, engineering, maintenance, validation, and support areas to solve problems and provide expertise on compliance issues and global quality policy requirements.

Salary Range: $90,816-$126,991/annually + 10% annual bonus

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

• Review and approval of complaints, deviations, incidents, and APQRs.
• Review, approve, and participate in the internal audit program.
• Maintains staffing at appropriate levels by coordinating staff needs with work commitments.
• Assures steps are taken to maintain positive personnel morale and development. Responsible for developing their direct reports and supporting the development of all personnel in the Department.
• Develops metrics to Key Performance Indicators to identify compliance risk in Deviations, Complaints, CAPAs and Events.
• Maintains current knowledge of GMPs, regulatory issues/guidelines for effective performance.
• Executes Gap Analysis and/or Risk Assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory and maintenance and engineering, are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, etc.
• Manages the CAPA system, ensuring actions are completed on-time. Supports all plant departments in defining and evaluating effectiveness checks.
• Plans audits and inspections, being responsible for ensuring the necessary documentation and the required experts are available upon request. Ensures that responses to the audits and inspections are timely.
• Supervises the investigation of problems to define nature, scope, and root cause of the problem. Issues reports with conclusions and actions needed to correct problems encountered.
• Utilizes managerial/technical skills to maximize inter/intra departmental continuous improvement activities.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
• Responsible for establishing and managing the departmental budget.
• Completes all training requirements, including all department-specific, compliance training, etc.
• Participates in any and all reasonable work activities as assigned by management.

Requirements

• BA/BS Degree in scientific field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience)
• 5-8 years' experience in a pharmaceutical or other highly regulated industry.
• Minimum of 3 years management experience
• Working knowledge of cGMP and GLP practices. Working knowledge of FDA, ISO, and ICH trends and guidelines.
• Effective communication (verbal and written) and solid interpersonal skills.
• Effective time management and organizational skills
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.