Senior Manager, Quality Assurance
Company: Disability Solutions
Location: San Diego
Posted on: May 2, 2024
Job Description:
Senior Manager, Quality AssurancePosition Summary:Catalent
Pharma in San Diego, CA is hiring a Senior Manager of Quality
Assurance (QA) at our Clinical Supplies facility. As a member of
the Site Leadership Team, you will partner with the General Manager
to create and sustain a site culture of Safety, Quality
performance, Operational Excellence, continuous improvement, error
reduction, regulatory compliance, and sound fiscal responsibility.
The primary responsibilities of the Senior QA Manager include
activities related to GMP (Good Manufacturing Practices) and
regulatory oversight, quality support to operations and
coordination of audit activities affiliated with assigned
projects.This is a full-time (on-site) position: Monday - Friday,
8am-5pm with flexibility in work schedule. 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 Pharma Solutions in San Diego is a premier
pharmaceutical chemistry development and manufacturing organization
supporting the pharmaceutical and biotechnology industries. We
focus on bringing client drug compounds from discovery to the
clinic with services that include analytical development,
pre-formulation testing, formulation development, GMP manufacturing
and stability storage and testing as well as Clinical Supply
Services.-- 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.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:
- Lead the development of site Quality Objectives, site Quality
Plans, Quality Management Reviews, etc. and oversee and execute all
Performance Management Program (PMP) actions for the site Quality
Assurance department. This includes professional development
counseling, informal and formal performance appraisals and
feedback, and talent development/succession planning.
- Internal Investigations on cGMP issues, trends, and customer
complaints. Review and approve GMP documentation, including SOPs,
Manufacturing Batch Records, validation protocols and reports, and
executed Batch Records for cGMP compliance and clarity.
- Oversee process integration and procedural harmonization with
other clinical supply sites, raw materials and finished goods
release processes, customer and regulatory audits, including
coordination and submission of Catalent responses. Communication
and escalation of quality issues to Site Leadership Team and QA
senior management.
- Lead programs for: QA department budget, Site Training,
Supplier and internal audits (including coordination with IACP
program). Site Environmental Monitoring, Site Label Control,
including review, release and approval process. Site Change
Control/ change management programs. Site Risk Management. Site
Supplier Management Program.
- In-process QA activities, including line clearance and room
release, in-process and receiving inspections, and raw
material/product sampling.
- Implement Global quality policies and standards and Catalent
network procedures at the site. Continuous process improvements,
particularly as a function of site deviation rate and recurrent
deviation rate.
- Maintain robust relationships, interactions, and communications
with client QA counterparts. Site Recall/Quality alert program,
Facility/equipment/process/analysis method/cleaning validation and
qualification program.
- Other duties as assigned.The Candidate:
- Minimum of a Bachelor's degree or equivalent knowledge and
experience is required. Six Sigma Green Belt and/or ASQ (American
Society for Quality) certification preferred.
- 8+ years of experience working in a chemical, pharmaceutical,
food or relevant industry with at least 5 years' experience in
QA/Regulatory Affairs areas with progressive responsibilities for
quality metrics, quality systems, deviations, investigations, CAPAs
(corrective and preventative action), supplier scorecards, safety
measures, and cost reductions. Clinical packaging experience highly
preferred (blinding, labeling, state licensing, storage,
distribution).
- Must have experience in managing people, providing leadership,
and implementing developmental plans for personnel.
- Must have direct experience and working knowledge of validation
principles, including validation of processes, equipment, systems,
analytical methods, cleaning, and transportation. Preferred
experience with: TrackWise, PowerBI, Microsoft Office, and JD
Edwards.
- Requires strong working knowledge of US and International cGMP
regulations and experience working directly with the local and
international regulatory agencies. Must have experience with a
variety of products and dosage forms.
- Must have a demonstrable record of implementing and maintaining
quality systems; laying out a strategic plan and overseeing the
tactical implementation, driving improved operational and quality
metrics. Experience in facilitating regulatory inspections
Understanding of QA/QC GMPs and in interpreting and enforcing
regulatory requirements. Comprehensive knowledge of regulatory
organizations and requirements.
- 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.
- Physical requirements: Ability to be on-site at the San Diego,
CA location is required. Individual may be required to sit, stand,
walk regularly and occasionally lift up to 40 pounds; ability to
communicate orally with customers, vendors, and co-workers. Regular
use of telephone and email. Hearing, vision, and speaking within
normal ranges is essential for normal conversations, to receive
ordinary information and to prepare or inspect documents. Good
manual dexterity for the use of common office equipment such as
computer terminals, calculator, copiers, and fax machines. Good
reasoning ability is important. Able to understand and utilize
management reports, memos, and other documents to conduct
business.Pay:
- The anticipated salary range for this role in San Diego, CA is
$152,000 - $163,750 annually. The final salary offered to a
successful candidate may vary, and will be dependent on several
factors that may include but are not limited to: the type and
length of experience within the job, type and length of experience
within the industry, skillset, education, business needs, etc.--
Catalent is a multi-state employer, and this salary range may not
reflect positions that work in other states.Why you should join
Catalent:
- Awesome employee activities:-- Movie Day, Monthly Birthday
Celebrations, Friday Bagel Breakfast, On-site Fitness Center with
machines, on-site yoga and HIIT classes, Sponsored Sports Teams,
and several other company-sponsored events that encourages positive
employee comradery, which contributes to effectively building
positive employee relationships, overall creating a positive work
environment.
- Environmentally friendly green initiatives with on-site
practices as well as regularly participating in Beach Clean-up
activities for community engagement.
- Defined career path and annual performance review and feedback
process. Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives. --
- Several Employee Resource Groups focusing on Diversity and
Inclusion.
- Competitive salary with bonus potential. Generous 401K
match--and Paid Time Off accrual. Medical, dental and vision
benefits effective day one of employment.--
- 152 hours of PTO + 10 paid holidays.
- Positive and fast-paced working environment focusing on
continually improving processes to remain innovative and
dynamic.
- Tuition Reimbursement--- Let us help you finish your degree or
earn a new one!
- 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 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 . 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 .
Keywords: Disability Solutions, National City , Senior Manager, Quality Assurance, Professions , San Diego, California
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