The Business Process Lead - Quality will have a strong ability to integrate seamlessly with the Quality team to drive business process changes that support efficiency gains and improve overall operations. This individual should be adept at engaging with both leaders and individual contributors to enhance processes and practices within the Quality work environment. With a focus on continuous improvement, the candidate will work collaboratively to create and implement strategies that ensure compliance with regulatory standards, boost operational efficiency, and support business objectives. Familiarity with ERP systems (JDE preferred) and Quality Management Systems (QMS) is essential. Knowledge of regulatory guidance such as USP, CFR, and EU is also required.

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:

Ensure compliance with relevant regulations (USP, CFR, and EU) and company standards across all Quality processes.Collaborate with cross-functional teams to drive Quality based continuous process improvements that may stretch across the end-to-end supply chain process.Develop evidence-based guidance to support process optimization and improvement initiatives.Create innovative solutions to address issues identified during Quality activities.Communicate process gaps and improvement actions to the management team, ensuring transparency and accountability.Apply familiarity with Cell and Gene Therapy processes to enhance relevant Quality activities.Analyze internal and external business challenges, recommending best practices to improve processes.Engage with executive leadership and individual contributors to champion and implement process improvement initiatives.Maintain professionalism and composure in high-pressure situations, ensuring continuous progress on initiatives.Utilize deep expertise in Quality standards and best practices to guide decision-making and actions.Manage high-priority projects, balancing competing deadlines and priorities effectively while ensuring successful outcomes.

The candidate:

Bachelor’s degree required, Master’s degree preferred (Industry related)5-7 years experience working in a GMP regulated environment5-7 years of Quality and/or Supply Chain experience3-5 years of ERP experience (JDE preferred)Microsoft Visio and Excel proficiency

The anticipated salary range for this position in Maryland is $110,000 to $131,000 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 401K152 hours PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity 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.

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.

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