Quality Manager, Customer Focus

Catalent

Philadelphia,PA  

2019-11-11 2019-12-11
manager quality administration pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



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 newly hired Quality Manager, Customer Focus must be flexible and have well-developed organizational skills and have the ability to interact with all levels of management. The Manager must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. They will be responsible for assisting in managing the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards.





This role will report to the Director of Quality and will reside on-site at our Philadelphia, PA site.







The Role



Primary Job Duties:





+ Maintains and supports Safety initiatives of the site and will establish and update procedures where appropriate.



+ Drives process efficiencies through Internal Auditing function.



+ Maintains contact with the customer with regard to client audit information and investigations.



+ Develop staff through training and professional growth opportunities. Use and extract information from the following systems: Documentum, TrackWise, and ComplianceWire.



+ Monitor and track training for staff compliance with GMP’s and internal procedures.



+ Support client projects by ensuring client requirements are implemented where appropriate to Catalent procedures and processes.









Key Customer Contact





+ Primary interface with customers on quality-related issues; must be adept in communication skills as well as have a good understanding of clinical supplies.



+ Handles customers and interfaces with them on a regular basis to solve Quality issues and satisfy customer needs. Must translate customer needs into internal directions/activities which lead to customer solutions.









Customer Audits:





+ Responsible for the scheduling, management, coordination, hosting, and leading/participation in Customer Audits and for ensuring 100% on-time responses to any observations.









Supplier Compliance Program:





+ Responsible for the management, coordination, and participation in the Supplier Audit Program and for ensuring 100% Supplier Compliance.



+ Performs off-site audits and audits via questionnaire and monitor supplier performance by gathering relevant data









Self-Inspection (Internal Audit) Program





+ Responsible for the management, coordination, and participation in the Self-Inspection Program and for ensuring 100% Departmental Compliance.



+ Performs and/or coordinates audits of GMP-Departments









Quality/Technical Agreements





+ Responsible to ensure Quality/Technical Agreements (QTAs) are in place where required (customers and suppliers); manage the QTA schedule for completion, coordinate and communicate with customers, and manage QTAs due for renewal.









The Candidate



Education and Knowledge/Skills:





+ Bachelors Degree with five years of experience working in a pharmaceutical industry with at least two years experience in QA/RA areas with progressive responsibilities. Experience managing people, providing leadership, and implementing developmental plans for personnel.



+ Full understanding of FDA cGMP regulations pertaining to clinical packaging and knowledge of Quality Assurance and Regulatory Compliance matters as applicable to the pharmaceutical industry.



+ Read and understand MSDS requirements and restrictions and will have previous auditing experience.



+ Candidate must have the ability to work effectively under high pressure with multiple deadlines along with being detailed oriented with good oral and written communication skills and good interpersonal skills.



+ Candidate must have computer skills with MS Office and capable of quickly learning other software including Documentum, TrackWise and ComplianceWire.



+ Candidate should be a creative thinker with sound business judgment and good negotiation and reasoning skills.









Physical Requirements:





+ Ability to work effectively under extreme pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.









We will identify candidates based on the following:





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops









Position Benefits:





+ Join a high growth and fast paced organization with a people focused culture



+ Global exposure, defined career path and annual performance review and feedback process



+ Competitive Medical, Dental, Vision and 401K













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 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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





Catalent = Catalyst + Talent







Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!







personal initiative. dynamic pace. meaningful work.







Catalent is the perfect place to grow your career if…





+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).











+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!











+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.











+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.











+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!











+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.











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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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