Job Summary

Responsibilities

The Compliance Offer works with the Compliance Management Team to administer and maintain the Quality Systems in place at the production unit from an FDA and global perspective. This function leads teams and projects identity and correct cGMP inadequacies and ensures a high-level of compliance and regulatory audit readiness. The incumbent provides expertise in deviation and compliant investigations, annual product reviews, and helps maintain the compliance of the CAPA systems, as well as, reviewing and approving necessary documentation for regulatory correspondence.

As needed, the Compliance Officer is independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the quality related deficiencies identified during the investigation process.

Job Responsibilities:

• Completes / reviews deviation investigations and helps define necessary corrective actions to ensure complete, thorough, accurate, and timely evaluation of non-conformances and prevention of recurrence.
• Completes / reviews investigations. As part of each investigation, gathers information from all product, as well as the risk to future operations. Maintains complaint information in FK gCMW KabiTrack systems.
• Accountable for commitments agreed upon with department management to comply with closure targets
• Reviews and analyzes manufacturing and laboratory analytical documentation for accuracy and compliance to establish procedures
• Serves as the compliance SME for all internal audits and supports external and regulatory authority audits
• Coordinates the collection of information for all regulatory requests and assists in the compliance to commitments made to all regulatory authorities
• Leads internal audit teams to inspect and remediate system and process noncompliance in the plant
• Supports compilation of annual product quality review
• Responsible for ensuring compliance with relevant operating procedures
• Assists in the execution of 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.)
• Updates and maintains all related quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to health, safety, environment, energy, and quality management systems, as per their roles and responsibilities.

Job Requirements:

• Bachelor's degree in Scientific or Engineering degree
• Minimum 3 (three) years of experience in the pharmaceutical industry in compliance, technical writing, and/or regulatory affairs

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.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.