Operations Compliance ManagerCatalent • Saint Petersburg, FL, US

Operations Compliance Manager

Catalent • Saint Petersburg, FL, US

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Operations Compliance Manager

St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The primary tasks performed by the Operations Compliance Manager will include leading a team of investigators working on proper continuous improvement effort and documentation of the proactive compliance initiatives, operational excellence analysis, impact, and corrective actions for the proactive compliance initiative management process for the site. The Operations Compliance Manager, will collaborate with members of multiple departments and QA to ensure all proactive compliance initiatives are investigated and documented properly in a timely manner. This leader will ensure that effective corrective and preventive actions are instituted in a timely manner.

This position is 100% on-site at the St. Petersburg site.

The Role

Manage complex and high-level proactive compliance initiatives, support OOS continuous improvement efforts, and collaborate with internal Catalent stakeholders to support the effective execution of the continuous improvement effort and preventive action planning systems.
Provide and maintain lead investigator, reviewer / approver, mentorship / coaching, rapid response, operational excellence analysis, technical writing, preventive action planning, and / or compliance monitoring systems (e.g., TrackWise) training at the site to support consistent and effective execution of the proactive compliance initiative management system.
Provide oversight to ensure the site proactive compliance initiative training program is maintained in compliance with regulatory and customer requirements.
Recommend process changes as a result of trends from preventive action planning / Complaints / Investigations.
May author other types of quality system documents as directed or assigned by QA management.
Ensures the adherence by team members to the standards of quality ruled by the current Good Manufacturing Practices and the Company's Quality Policies.
Effectively manages and schedules continuous improvement effort assignments and ensure compliant documentation by team members. May include directly completing complex / critical proactive compliance initiative continuous improvement efforts at a high-level of expertise with technical writing and GMP understanding.
Effectively compile and interpret data and advanced level ability with identifying the impact of proactive compliance initiatives to product quality in collaboration with subject matter experts. This includes clearly defining problems, collecting, and organizing existing data, comparing potential causes with relevant data and processing standards, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices.
All other duties as assigned.

The Candidate

Requires a bachelor's degree in a technical / scientific field (Chemistry, Microbiology or Engineering) relevant to pharmaceutical manufacturing.

Requires a minimum of 5 years' experience in a pharmaceutical manufacturing environment.

Requires a minimum of 3+ years' experience with continuous improvement effort systems or proactive compliance initiative management.

Solid understanding of cGMPs as they apply to documentation and proactive compliance initiative systems.

Pathwise or other training / certifications related to root cause continuous improvement effort practices.

Direct, hands-on experience with proactive compliance initiative management and proactive compliance initiative management systems; knowledge of compliance monitoring systems (e.g., TrackWise) is preferred.

Must have experience in advanced operational excellence analysis tools (Fishbone, 5-Why, Brainstorming, FMEA, Process Mapping, Error-proofing, etc.). Demonstrated facilitation, problem solving, and analytical skills.

Knowledge of Quality Systems.

Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems.

Proficient technical writing skills are required.

Must be well organized, an effective communicator at multiple levels, able to grasp system concepts and communicate their applications.

Must possess strong technical writing skills, with a command of grammar, punctuation and great attention to detail.

Strong oral and written communication skills, with ability to speak effectively before groups of internal and / or external customers, regulators, or employees.

Ability to work with a wide variety of colleagues within Technical Services and from other departments as well as different levels of Management.

Working knowledge of cGMP and pharmaceutical manufacturing Regulations.

Ability to solve problems with little guidance. Ability to identify the most efficient method in order to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individuals may be required to sit, stand, walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.

Why You Should Join Catalent

Competitive medical benefits and 401K

152 hours of PTO + 8 Paid Holidays

Dynamic, fast-paced work environment

Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Personal initiative. Dynamic pace. Meaningful work.

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Compliance Manager • Saint Petersburg, FL, US