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Senior Manager, Quality Assurance

Position Summary:

Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility . As a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of audit activities affiliated with assigned projects.

This is a full-time (on-site) position: Monday – Friday, 8am-5pm with flexibility in work schedule.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

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.

The Role:

• Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc. and oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department. This includes professional development counseling, informal and formal performance appraisals and feedback, and talent development/succession planning.

• Internal Investigations on cGMP issues, trends, and customer complaints. Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity.

• Oversee process integration and procedural harmonization with other clinical supply sites, raw materials and finished goods release processes, customer and regulatory audits, including coordination and submission of Catalent responses. Communication and escalation of quality issues to Site Leadership Team and QA senior management.

• Lead programs for: QA department budget, Site Training, Supplier and internal audits (including coordination with IACP program). Site Environmental Monitoring, Site Label Control, including review, release and approval process. Site Change Control/ change management programs. Site Risk Management. Site Supplier Management Program.

• In-process QA activities, including line clearance and room release, in-process and receiving inspections, and raw material/product sampling.

• Implement Global quality policies and standards and Catalent network procedures at the site. Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate.

• Maintain robust relationships, interactions, and communications with client QA counterparts. Site Recall/Quality alert program, Facility/equipment/process/analysis method/cleaning validation and qualification program.

• Other duties as assigned.

The Candidate:

• Minimum of a Bachelor’s degree or equivalent knowledge and experience is required. Six Sigma Green Belt and/or ASQ (American Society for Quality) certification preferred.

• 8+ years of experience working in a chemical, pharmaceutical, food or relevant industry with at least 5 years’ experience in QA/Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems, deviations, investigations, CAPAs (corrective and preventative action), supplier scorecards, safety measures, and cost reductions. Clinical packaging experience highly preferred (blinding, labeling, state licensing, storage, distribution).

• Must have experience in managing people, providing leadership, and implementing developmental plans for personnel.

• Must have direct experience and working knowledge of validation principles, including validation of processes, equipment, systems, analytical methods, cleaning, and transportation. Preferred experience with: TrackWise, PowerBI, Microsoft Office, and JD Edwards.

• Requires strong working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies. Must have experience with a variety of products and dosage forms.

• Must have a demonstrable record of implementing and maintaining quality systems; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. Experience in facilitating regulatory inspections Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements. Comprehensive knowledge of regulatory organizations and requirements.

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

• Physical requirements: Ability to be on-site at the San Diego, CA location is required. Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business.

Pay:

• The anticipated salary range for this role in San Diego, CA is $152,000 - $163,750 annually. 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:

• Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.

• Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.

• Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

• Several Employee Resource Groups focusing on Diversity and Inclusion.

• Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment.

• 152 hours of PTO + 10 paid holidays.

• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• GymPass program to promote overall physical wellness.

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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.

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .