Manager, Quality Assurance

Catalent Morrisville , NC 27560

Posted 3 months ago

Job Description:

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

The Manager, Quality Assurance will report directly to the Director of Quality

Overview

The Quality Assurance Manager is responsible for coordinating and implementing activities to attain strategic objectives within a single functional area or department and looks to his or her direct supervisor or other peers within the industry for guidance. In addition, the manager is able to establish goals and objectives, supervise work practices for direct reports, interprets and executes policies and procedures that typically affect organizational units. This position will interact with other departments or divisions within Catalent. At the senior level, this position requires extensive independent judgment. At a more experienced level, the manager can utilize the confidence of knowledge gained through experience in the position to further motivate individuals towards achieving departmental goals. Comply with divisional and site Environmental Health and Safety requirements.

The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

The Role

  • Provide guidance to employees within function or department.

  • Write, revise, and/or review SOPs for approval and recommends modification to operating policies.

  • Review and approve investigations, deviations and CAPA's for both laboratory and manufacturing operations.

  • Review and evaluate performance issues with employees in group.

  • Staffing responsibilities for a single functional area or department of Catalent with moderate financial responsibilities.

The Candidate

  • Bachelor's degree in chemistry or closely related field with 5-7 years related experience or an Associate's degree in chemistry or closely related field with 7-9 years directly related experience

  • Minimum of 3 years in a supervisory position with direct reports required

  • Prior experience with investigations, deviations and CAPA's in both a laboratory and manufacturing setting

  • Candidates with prior or current roles within a CMO/CDMO is preferred

  • Knowledge of cGMP, GLP, ICH, and USP regulations or guidelines

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually + 7 paid holidays

Leadership Competencies for Performance and Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develop

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. More products. Better treatments. Reliably supplied.

Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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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