Director, QA Batch Release
Company: Disability Solutions
Location: Severn
Posted on: October 27, 2024
Job Description:
Director, Quality Assurance Batch ReleasePosition Summary
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.-----The Director, Quality
Assurance Batch Release provides strategic oversight and leadership
to QA Batch Record Review and Release supporting clinical and
commercial drug substance and drug product manufacturing. The
Director ensures project objectives are met to a high-quality
standard and according to commitments while ensuring current Good
Manufacturing Practices (cGMPs) compliance for manufacturing of
biological products, and compliance to US, EU regulations, and
other Boards of Health (BOH) as applicable.-- --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 RoleThe primary responsibilities of this
position include providing direction for programs, processes and
team members of the department, related to batch record review and
disposition supporting clinical and commercial drug substance and
drug product manufacturing. The Director, Quality Assurance Batch
Release serves as the Quality counterpart for the Senior Director,
Commercial Operations in managing the activities of the Commercial
Vertically Integrated Team (cVIT) as well as setting the tone for
compliance and on time completion of department deliverables. This
position plays a key role defining the values, culture, and goals
for the site.--
- Directs the batch record review and lot disposition activities
to ensure product delivery in compliance with applicable regulatory
submissions and approvals and within prescribed timelines--
- Outlines and executes on department and business objectives,
identifying continuous improvement initiatives, monitors progress
of deliverables, and provides support to staff to ensure
success--
- Provides strategic oversight and leadership to client
representatives to ensure project objectives are met to a
high-quality standard and according to commitments. Resolves and
assists in solving compliance and customer issues--
- Participate in the Quality Metric review process, assess data
for adverse trends, develop solutions and oversee implementation
related to area--
- Facilitates QA support and works closely with other Catalent
functional units including Manufacturing, Validation, Facilities
Engineering, and Quality Control to assess and resolve quality
issues with regards to the facility and products
manufactured--
- Develops and implements procedures, programs and policies that
support GMP operations and overall compliance strategy--
- Continuous review of all systems and procedures (SOPs) for
efficiency, best practices and regulatory compliance improvements
and adherence with Corporate policies.--
- Work with senior management to initiate new client proposals
and projects. This includes analyzing client proposals for resource
allocation and QA costs generated by Business Development.----The
Candidate
- Bachelors Degree in Science or related field required
(Chemistry, Microbiology or Biology preferred)--
- 10+ years of relevant work experience in pharmaceuticals,
preferably biotechnology within a Quality role--
- 8+ years of leadership experience including performance
management--
- Comprehensive and practical working knowledge of applicable GMP
regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other
applicable regulations and guidance--
- Knowledgeable and/or exposure to biological manufacturing
processes including microbial and cell culture cell banking,
fermentation/cell culture, purification and fill/finish. Exposure
to contract manufacturing a plus.--
- Ability to quickly learn new and novel manufacturing processes
supporting new clients--
- Ability to self-direct and adapt to changing priorities--while
working effectively under pressure to meet deadlines
- Excellent communication/interpersonal skills, strong attention
to detail, proven technical writing and editing skills
- 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 experiencePayThe anticipated
salary range for this position in Maryland is $188,320 - $258,940
plus variable compensation. 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
- Defined career path and annual performance review and feedback
process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives
- Dynamic, fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match and paid time off accrual
- Medical, dental, and vision benefits effective day one of
employment
- Tuition reimbursementCatalent 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 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, Reston , Director, QA Batch Release, Executive , Severn, Virginia
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