Operations Compliance Specialist

Operations Compliance Specialist

Position Summary :

• Work Schedule : Monday-Friday core hours 8am-4 : 30pm
• 100% on-site (San Diego)

Catalent Inc. is a leading global Contract Development and Manufacturing Organization (CDMO) and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management primary and secondary packaging complex labeling services clinical storage distribution and clinical returns and destruction and will also include stability chambers. Located less than a mile from Catalents West Coast early-phase oral drug product development center of excellence customers choosing this convenient Catalent location can now enjoy a fully integrated development clinical supply manufacturing and distribution solution.

The Operations Compliance Specialist ensures patient safety regulatory compliance and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering authors clear and comprehensive investigation reports and proposes effective Corrective and Preventive Actions (CAPAs) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools the Specialist drives root cause analysis (RCA) leads cross-functional problem-solving sessions and develops Standard Operating Procedures (SOPs) and work instructions to strengthen operational standards.

The Role :

The Candidate :

Pay :

Why you should join Catalent :

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives : Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and / or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and / or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers :

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Required Experience :

IC

Key Skills

Financial Services,Information Technology,Cost Control,Corporate Risk Management,Law

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 80000 - 90000