Manager, QA OTF

Position Summary

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’s Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Manager, QA OTF Support is responsible for providing quality oversight for the “QA on the Floor” program in accordance with Catalent policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations on the floor to resolve manufacturing issues. This position is required to be present on the floor for 70% of the day.

This position will follow a night schedule with start time between 7PM-9PM Monday-Friday with 8-hour shifts and is 100% on site at our Harmans/BWI, MD facility.

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:

• Provide oversight of the “QA on the Floor” program; manage the day to day operations in assigned area of the QA OFT department.

• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines; build effective teams that apply their diverse skills and perspectives to achieve common goals; drive engagement and create a culture where employees are motivated to do their best.

• Oversee daily activity for the group to ensure quality results Performance management for direct reports; drives the “Quality on the Floor” program by facilitating the desired ‘way of working’ and a quality culture; plans and coordinates the activities of the OTF team to ensure coverage for all manufacturing activities

• Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing and operations support; develop and update relevant procedures.

• Monitor, participate and oversee the real time batch record review process, including escalation of issues while on the floor; manage the resolution of QA OFT investigations and CAPAs; ensure quality events are captured, investigated and closed appropriately in the Trackwise system.

• Ensure that own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIF

• Ensure manufacturing compliance with applicable procedures and batch records; review manufacturing shop floor documentation, including logbooks, calibrations etc

• Embrace and actively drive Practical Process Improvements (PPI). Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

• Partner with manufacturing and key stakeholders to prioritize projects aligning with the quality goals and objectives.

• Actively participates in training activities, managing their individual training plan; proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.

• Other duties as assigned.

The Candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 6+ years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 8+ years’ experience in Quality Assurance/Quality Control/Maufacutring within biologics, biopharmaceuticals, or a regulated industry.

• 2+ years Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.

• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs; knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.

• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.

• Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred.

• Ability to quickly learn new and novel manufacturing processes supporting new clients; requires the ability to produce results in a fast-paced environment to meet client deadlines

The anticipated salary range for this position in Maryland is $118,720-$163,240 plus annual bonus, when eligible. 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:

• 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

• Dynamic, fast-paced work environment

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• Wellhub 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.

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) .