Catalent Pharma Solutions QA Manager, Manufacturing in San Diego, California
Catalent Pharma is actively hiring for a Quality Assurance Manager (Manufacturing) at our San Diego, CA site. This individual will be responsible for high level QA functions such as critical manufacturing decisions, client meetings, audits, and correspondence, and for managing employees who are evaluating the compliance of manufacturing and manufacturing support documents such as batch records, protocols, cleaning verification data, raw material release data, etc. The QA Manager will function as a management role, within the QA department, and demonstrates excellent leadership, communication, critical thinking, and organizational skills.
The Role (daily responsibilities)
Independent review and approval of deviation and investigation documentation. This includes thorough evaluation of the root cause of the issue and the ability to effectively communicate the evaluation to individuals in the science and manufacturing departments, as well as clients.
Oversees the activities of multiple direct reports and determination of growth and development opportunities
Takes a lead role in client audits, client meetings, and other client correspondence. Performs both internal and external audits.
Effectively works with other departments to streamline and improve systems
Tracks, analyzes, and reports metrics pertinent to manufacturing QA support operations
Reviews and gives approval of facility validation protocols, data, and reports
Reviews and gives approval of controlled documents such as protocols, master batch records, specifications, and standard operation procedures
Independent review of executed batch records, cleaning verification data, and raw material release data
The Candidate (requirements)
BS science degree, preferably in Chemistry or Biochemistry, and a minimum of 7 years of applicable cGMP industry experience. Manufacturing and QA experience may be considered applicable
Must be familiar with applicable cGMP regulations and related systems and have the ability to make independent decisions based on those requirements. Requires the ability to apply scientific knowledge and understanding of the industry regulations to applicable internal issues.
Proven abilities in leadership and personnel management.
Strong written and oral communication skills. Ability to read, write, and comprehend routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization. Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Excellent accountability, high attention to detail, and strong organizational skills
Ability to deal with problems involving several concrete variables in standardized situations.
Catalent’s standard leadership competencies that are used to interview and for Performance & Development:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Potential for career growth within an expanding team
Defined career path and annual performance review and feedback process
Medical, Dental, Vision and 401k are all offered from Day One of employment
Generous paid time off and holidays
About Catalent San Diego
Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.
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 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.
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.
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
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.