Manager, Quality - Bioanalytical

Manager, Quality

• Bioanalytical

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 Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Manager of Quality who is responsible for the management of the day-to-day activities of the BioAnalytical Quality group. The manager will manage direct reports that function to perform audits of laboratory facilities and data. The manager will also manage direct reports that are responsible for management of non-conformances including deviations, investigations and corrective/preventive actions. The manager will assist in providing oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.

This is a full-time role position: Monday

• Friday, days. 9:00AM - 5:00PM On Site

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

• Support the Catalent Way by having a patient first mentality, a passion for excellence, integrity and respect, striving to exceed customer expectations, delivering innovative solutions, driving accountability among individuals, supporting employee engagement and actively pursuing improvements in our processes.

• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification and implementation of improvement opportunities for established Quality Systems, processes, procedures and training to support Deviations, Investigations, CAPA and Change Control processes.

• Develops and implements strategies to facilitate compliance and foster internal and client relationships.

• Develops and provides training to support consistent and effective execution of the Quality Systems.

• Accountable for the Investigation and CAPA Management Systems by managing complex and high-level deviations, supporting investigations, and collaborating with internal Catalent stakeholders.

• Support change control review, implementation and approval.

• Drives continuous improvement through leading cross functional teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements and KPI performance improvements.

• Responsible for direct reports' performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback and addressing performance related concerns and issues promptly.

• Maintains high level understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the Quality Director.

• Monitor site compliance to FDA, EU, and all other applicable requirements and ensure site procedures align with Corporate policies.

• All other duties as assigned;

The Candidate

• Doctorate Degree in STEM discipline with 4+ years related experience; OR Master's Degree in STEM discipline with 6+ years related experience; OR Bachelor's Degree in STEM with a minimum of 8+ years related experience;

• Prior leadership 3+ years' experience required;

• Help to identify department objectives to align with site goals. Regularly communicate to team and department about priorities;

• Manage strategic or continuous improvement activities;

• Use comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead direct reports;

• Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe and professional manner with supervisor, group members and other departments as necessary, in a professional manner;

• Ability to effectively carry out and implement changes that support the Quality Management System;

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 Hours PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Competitive salary

• Community engagement and green initiatives

• 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 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.