Manager, QA Critical Systems

Provides QA support and guidance to Plant Engineering, Metrology, Maintenance, Cleaning Validation, and Equipment Validation. Responsible for developing, evaluating, and ownership of all quality characteristics of the plant facilities, utilities, and maintenance. and equipment (FUME) quality system.

Salary Range: $90,816 - $126,991

Position is eligible to participate in an annual bonus plan with a target of 10% of the base salary.

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

• Owner of the facilities and equipment quality system (FUME). Responsible for developing, evaluating, and ownership of all quality characteristics of the plant facilities and equipment quality system (FUME Quality System).
• Manage a team of Quality Engineers.
• Provides quality oversight for software validation, equipment qualification, and facility commissioning and qualification, and validation. Drafts and executes protocols/validations/qualifications.
• Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc.). Analyzes data and implements both corrective and preventative actions to enhance processes.
• Executes Gap Analysis and/or Risk Assessments to ensure evaluation of critical systems and equipment are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Provides QA review and approval of deviations and validation protocols/reports. Ensures completeness, accuracy and compliance of all documentation. CAPA management of critical systems, metrology, and validation areas.
• Interacts with the regulatory officials to convey the compliance level of the facilities and equipment quality system during regulatory inspections.
• Leads, manages, or participates in quality projects and teams to implement improvements to the facilities and equipment quality system infrastructure to meet regulatory requirements.
• Independently and proactively seek new information to:
• Assure current status with compliance and regulatory issues through evaluation of available documentation, e.g., other company's 483/Warning Letters, cGMP Trends, new FDA Guidance Documents, PDA, ISPE etc.
• Share with site QA and all other applicable Fresenius Kabi USA departments.
• Provides training to appropriate personnel related to facilities and equipment quality system.

• Trends and tracks critical system data as appropriate.

• B.S. degree in a technical science is required. Engineering degree is highly preferred.
• Minimum 5 years' experience in a highly regulated industry required.
• 5 years' experience in the pharmaceutical industry highly preferred.
• 5 years' experience in change control preferred.
• Experience in qualification and validation practices required.
• Working knowledge of aseptic processing is highly preferred.
• Working knowledge of cGMP practices to include 21 CFR Part 210, 211 and Part11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines.
• Good organizational and leadership skills, high level of attention to detail, excellent oral and written communication skills with the ability to effectively interact at all levels.
• Experience in leading cross functional teams, propelling change and driving projects to completion.
• Skilled in the application of continuous process improvement tools (e.g., six sigma, lean manufacturing, DMAIC)
• CQE or Black Belt certification a plus.
• Experience with Trackwise and EDMS preferred.
• Travel 10-20% as needed.

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.

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.