Position Summary

The Head of Quality-Maryland is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to ensure the site is compliant with regulatory, Corporate, and customer requirements. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Head of Quality-Maryland is responsible for Quality, Validation and Quality Control and is the most responsible person for batch disposition. The Head of Quality will provide project guidance and support while working with customers to resolve quality concerns as appropriate.

The Role

• Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.

• Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.

• Interface with all other departments to ensure compliance with cGMP.

• Monitor site compliance to FDA, EU and all other applicable requirements.

• Analyze, resolve, or assist in solving compliance and customer issues.

• Ensure regulatory and customer audits are managed successfully and any responses are submitted in a timely manner.

• Prepare, approve, and manage Quality departmental budget.

• Approve or reject, starting materials, packaging materials, and intermediate, finished products, and evaluate batch production records.

• Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures is performed on manufactured products.

• Review and approve Site Annual Product Reviews.

• Ensure that required validation activities are completed.

• Responsible for ensuring the environmental monitoring and control of the manufacturing environment and plant hygiene.

• Require approval and monitoring of suppliers of materials. Ensure the proper designation and monitoring of storage conditions for materials and products.

• Ensure that Document Control activities are compliant with FDA, EU and other applicable requirements and that controlled documents are maintained in an orderly manner to allow rapid retrieval when required.

• Being part of the Site Leadership Team representing the QRA function for the site and supporting site mission/strategy

The Candidate

• Bachelor’s degree in chemistry or closely related field (e.g. natural sciences, engineering) is strongly preferred

• 10-12 years’ directly related experience in pharmaceutical fields including managerial roles

• Experience with sterile drug product manufacturing and drug substance manufacturing is strongly preferred

• Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred

• Extensive knowledge of Quality Assurance and Quality Control

• Demonstrated expertise in effectively leading a sizeable organization with multiple levels and shifts, consisting of at least 100-150 employees.

• Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments

• Ability to bring projects to a timely completion using Catalent systems

• 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

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

• 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.

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