Job SummaryThe Sr. Manager, GxP Compliance Officer (GCO) assures that all manufacturing sites and R&D Centers having activities with US-FDA are in compliance with US-FDA regulations, including but not limited to, cGMPs, cGLPs, and electronic records. This includes global facilities within Fresenius Kabi for importation of API or finished products to the US market. This position organizes and promotes company-wide US-FDA quality and compliance improvement and compliance improvement efforts.
Salary Range: $172,000-$192,000 based on experience
• Position is eligible to participate in a bonus plan with a target of 14% of the base salary (include only if applicable to the grade level)
• 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.
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.
Responsibilities- Responsible for leading, coordination, verification and tracking of global compliance activities within the pharmaceutical division
- Evaluation of Investigations and Changes that could have an impact on regulatory commitments
- Identification and remediation of plant quality and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etc
- Support plant on strategy and compliance plans for identified gaps
- Lead/manage working groups to ensure mitigation plans are executed
- Responsible for specific preparation of manufacturing sites and I&D Centers for upcoming US-FDA inspections, including but not limited to:
- Training of plant staff for general inspection aspects and behaviors, as well as specific training for subject matter experts
- Performance of mock inspections to evaluate the plants readiness for FDA inspection
- Design and deliver need-based training to specific plants in response to identified gaps
- Direct participation and support during US-FDA inspections (inspection room and back office), including:
- Immediate guidance and support during inspections
- Support and guidance in preparing response to FDA-483 observations
- Independent review of Effectiveness of assigned FDA-483 CAPA
- May also include inspections by local authorities when related to Mutual Recogition agreements
- Responsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectations
- Strategic optimization and harmonization of cGMP and quality related processes to continuously improve pharmaceutical quality and compliance of Fresenius Kabi products
- Preparation of global quality management documents (e.g. SOPs, guiding documents, working instructions)
- Contribution, execution and management of global projects
- Collaborate with other corporate quality functions on the execution of strategic goals
- Communicate findings and risks to plant management as well as senior quality management
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
Requirements- Minimum of Bachelor's degree required. Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable.
- Accomplished US-FDA compliance expert.
- Experience: 8+ years including practical experience in pharmaceutical industry and/or US-FDA.
- A thorough knowledge of drug transfer processes, manufacturing processes for aseptically filled, terminally sterilized and lyophilized pharmaceuticals, cGMPs, ICH guidelines, regulatory compliance.
- Professional experience in pharmaceutical industry, including technological understanding of manufacturing pharmaceuticals and combination products, aseptic processes, validation and qualification, risk management, root cause analysis and investigation management is required to be successful in this position.
- Previous experience in executing and/or managing GxP audits or inspections a preferred
- Ability to effectively interact with and influence plant personal and leadership regulators, global partners or affiliates, industry executives, trade organizations.
- Established contacts to US-FDA are beneficial
- Strong analytical problem-solving experience is essential. Demonstrated prior experience in leading and motivating teams to conceptualize and develop innovative and creative solutions that are robust and sustainable.
- Ability to manage multiple complex situations, where precedent may not have been established. Ambiguity and uncertainty will often be associated within the framework of decision making facing this individual.
- Ability to travel frequently (both domestically and internationally) is required.
- Project Management, working in a Quality Management System and strong communication skills are required for this position.
- Bilingual English/Spanish preferred
- 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 InformationWe 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.
