The Senior Manager, Quality Assurance Data Integrity Compliance performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
Supports internal training on quality assurance/data integrity requirements, processes, and procedures. Supports the organization with responsibility for creating training materials, delivery of training to staff, proactively fostering a culture of Data Integrity, and resolving Data Management issues.
Maintains the site Data Integrity Compliance plan and provides quarterly updates to senior leadership team to determine appropriate actions to be taken to ensure ongoing compliance with Catalent and Regulatory expectations.
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 role:
- Assures compliance with cGMP regulations, Catalent standards, and applicable regulatory requirements.
- Resolves Quality Assurance issues complex in scope following cGMP regulations and Catalent standards.
- Drives improvement of processes of the quality system.
- Authors, revises, reviews, and approves controlled documents in compliance with cGMP regulations.
- Performs assigned tasks and work to achieve company goals and department objectives.
- Tracks and/or manages Corrective and Preventative Action (CAPA) actions as they apply to Data Integrity Compliance.
- Assists in customer and/or regulatory audits.
- Establishes and chairs the Data Integrity Governance Team meetings.
- Provides assessments and status updates to aid Data Integrity Governance team’s actions to maintain and proactively improve data integrity.
The candidate:
- Bachelors Degree in Science or related field required (Chemistry, Microbiology or Biology preferred)
- 5+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role
- Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Experience in data review, 21 CFR Part 11 instrumentation compliance.
- Knowledgeable in Quality Management Systems (FDA or ICH approach to risk management and QMS). Demonstrated ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints.
- Ability to audit GxP processes and Quality Management Systems.
- Experience with review of CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit reports.
The anticipated salary range for this position in Maryland is $152,800-$210,000 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why you should join Catalent:
- Competitive medical benefits and 401K
- 152 hours 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.
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 DisabilityAccommodations@catalent.com. 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.
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