"Alerted.org

Director of Quality – Malvern PA

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.

Catalent Micron Technologies Malvern facility specializes in particle size reduction technologies and integrated analytical services for the pharmaceutical industry. It is equipped with advanced systems to handle highly potent and cytotoxic compounds, and provide leading analytical services associated with particle size engineering and material characterization testing from early-stage development to commercialization.

As a member of the senior management team, ensure an effective Pharmaceutical Quality Management system is in place. The Quality Director will provide leadership and daily management of the site Quality Assurance and analytical laboratory Departments. Quality Director will also be responsible to provide support to both the Malvern site business unit (BU) operations, as well as to the corporate Quality function.

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:

+ To ensure the Quality function complies with Health, Safety and Environmental requirements and employees adhere to the “Standards of Business Conduct”

+ To determine, establish and maintain comprehensive systems that establish documents and monitor GMP Quality and ISO standards and that meet Catalent, Regulatory and Customer requirements.

+ To ensure that the Malvern site complies with all Applicable Laws relative to Good Manufacturing Practice and ensure that all regulatory licenses are maintained and renew in line with different countries’ requirements as appropriate for the business.

+ Manage the team against the site and Quality strategy objectives

+ To develop a Quality culture on site, such that the Quality team provides leadership and coaching to ensure GMP best practices are embedded throughout the site.

+ To continually review the operation of the Quality function on site, and deliver a program of continual improvement

+ To manage the Quality budget, ensuring well defined resource modelling.

+ To act as a primary contact for senior Quality professionals within our customer organizations to ensure compliance and customer service standards are met.

+ Other duties as assigned.

The Candidate:

+ Bachelor’s Degree in Chemistry, Biology or related scientific field required. Master’s degree in Chemistry, Biology or related scientific field preferred;

+ A minimum of ten (10) years’ experience successfully leading a customer focused quality function including QA, QC and batch release within an API manufacturing environment or pharmaceutical manufacturing environment.

+ Has participated in managing and fronting Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, FDA, etc.

+ 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:

+ Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).

+ Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions.

+ Paid Time Off Programs including Vacation, banked time, and personal time.

+ Employee Reward and Recognition Programs.

+ Opportunities for professional and personal development.

**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 [email protected] . 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 [email protected] 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) .