Compliance Officer

Fresenius Kabi; Melrose (MA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Wellness program

Job summary

Fresenius Kabi in Melrose, MA is seeking a Compliance Officer to maintain Quality Systems from an FDA and global perspective. The role leads teams to identify and correct cGMP inadequacies and ensures audit readiness.

It requires expertise in deviation investigations, annual product reviews, and CAPA documentation. You will investigate process deviations, determine root causes, and initiate corrective actions, ensuring compliance with SOPs and regulatory requirements; excellent written and

Qualifications

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

Responsibilities

• Completes or reviews deviation investigations and defines corrective actions to prevent recurrence.
• Gathers information from product data and assesses risk to future operations; maintains complaints in FK gCMW KabiTrack.
• Accountable for meeting closure targets per department management.
• Reviews manufacturing and laboratory documentation for accuracy and regulatory compliance.
• Serves as the compliance SME for internal audits and supports regulatory authority audits.
• Coordinates information for regulatory requests and assists in meeting commitments to authorities.
• Leads internal audit teams to inspect and remediate system noncompliance in the plant.
• Supports compilation of annual product quality review.
• Responsible for ensuring compliance with operating procedures.
• Assists in GAP analysis and risk assessments across manufacturing, laboratory, maintenance and engineering.
• Updates and maintains quality management systems and performs trend analysis.
• All employees must comply with health, safety, environment, energy and quality programs.

Education

Bachelor's degree in Scientific or Engineering degree

Job description

Job Summary

Salary Range: $80,000 to $100,000

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

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

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, andwellness 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.