Director, Quality
Company: Disability Solutions
Location: Philadelphia
Posted on: April 25, 2024
Job Description:
Position: Director QualityLocation: Philadelphia, PAPosition
Summary: ----The Quality function is to build, monitor, and sustain
a robust and effective quality system that delivers reliable,
high-quality products that meet all customer and regulatory agency
requirements and expectations. Components of the quality system
establish the requirements for and measure how Catalent complies
with all applicable regulations and guidance world-wide, including
but not limited to, good manufacturing practice/quality system
requirements of the Food and Drug Administration, state boards of
pharmacy, European, South American, Japanese, and Australian
agencies and other international and/or local health
authorities.The Director of Quality is responsible for providing
leadership and Quality Management support within each of the
Clinical development supply division. This individual will have
responsibility for Quality aspects related to Quality Systems,
Finished Product Batch Release, Change Control, and Customer
relations.The Role: --
- Provides direction and guidance to the Quality Disposition,
Materials Sampling Quality Assurance, Regulatory and Compliance
Quality Assurance, and Validation Quality Assurance.
- Management responsibilities include professional development,
performance appraisals, and employee counselling for direct
reports. Assigns work and reviews workload for all direct reports.
Supervises staff by establishing goals that will increase knowledge
and skill levels, and by delegating tasks commensurate with skill
level.
- Recommends courses of action on all management/human resources'
matters, including salary administration, transfers, hiring,
terminations, and position description preparation.
- Promotes, implements, and maintains quality initiatives of
processes and programs to assess compliance with regulations,
Global and Site SOPs, and client requirements.
- Provides to the Operational CDS and Quality organization
consultation, and interpretation of regulations/guidelines related
to GXPs focused mainly on good clinical trials, as applicable.
- Writes and approves Quality unit SOPs and Forms, as needed.
Approves Operational CDS SOPs and Forms. Supports harmonization of
worldwide Quality operating procedures as needed.
- Provides leadership for Data Integrity and Computer System
Validation documentation review and approval for instruments,
equipment, and systems used in GXP Operations throughout the system
life cycle.
- Other duties as assigned.The Candidate: --
- BS or BA in Chemistry, Biological Sciences, or other related
scientific discipline or equivalent experience.
- 15 + years of Scientific or Quality Assurance in clinical
trials packaging, in addition of commercial manufacturing and
packaging
- Clear understanding of cGMPs including clinical trials.
- Open and clear communication with direct reports.
- Communicates clearly with internal and external clients, both
verbal and written.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, Lower Merion , Director, Quality, Executive , Philadelphia, Pennsylvania
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