Manager, Supplier Quality
Company: Disability Solutions
Location: Severn
Posted on: October 25, 2024
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Job Description:
Manager, Supplier Quality--Position SummaryCatalent 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's Harmans/BWI, MD facility is a FDA-licensed,
state-of-the-art CGMP manufacturing facility for Gene Therapies.
The campus features two manufacturing facilities: The Harmans/BWI-1
EMA and FDA approved facility, at approximately 200,000 sq. ft.,
houses 10 CGMP manufacturing suites, fill/finish, central services,
testing labs, and a warehouse. The Harmans/BWI-2 facility, at
approximately 145,000 sq. ft., is under development and will house
8 CGMP manufacturing suites and cold storage warehousing. Both
facilities support Phase 3 through commercial manufacturing of
advanced therapeutic products including AAV and other viral
vector-based therapies and vaccines.The Manager, Supplier Quality
is responsible for the management and oversight of the core quality
systems related to Supplier Quality Management, including supplier
qualification, quality agreements, audits, complaints, CAPA
tracking, supplier change and alert notifications and risk
management. --This role is also responsible for compiling, trending
and reporting key Supplier Quality metrics for Senior Leadership
review. This role may also engage on all aspects of raw material
management including material qualification, specifications,
reduced testing programs and warehousing practices. This role
manages the Supplier Quality team which supports all Catalent Gene
Therapy sites. --This position is 1st shift M-F 8AM-PM and 100% on
site at Harmans/BWI, Maryland facility.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: ----------- --Manages, coaches and develops
the QA staff responsible for Supplier Quality Management across the
Catalent Gene Therapy sites.--------- --Engages with the global SQM
team to assure Gene Therapy sites comply with all corporate
Catalent policy and standards requirements for supplier quality;
negotiates supplier quality agreements on behalf of Gene Therapy
sites to assure compliance with Catalent expectations; manages &
advises team assessing supplier quality alerts and change
notifications to determine impact to user sites within the expected
turn-around time --------- --Manages Gene Therapy Supplier Audit
Schedule and Annual audit planning; tracks Supplier Complaints and
CAPA to closure in a timely manner; responsible for managing BU use
of the Global TrackWise Supplier quality modules; responsible for
and administers the Risk management system and track completion of
risk assessments--------- --Assembles critical metrics from
applicable departments, analyze using appropriate tools to identify
trends and report via a PowerPoint presentation to be reviewed by
Senior Leadership on a periodic basis. Track action items for
completion; compiles pertinent QA metrics for Senior Leadership
review------- --Aids improvements and process mapping of all
supplier quality related processes, updating SOPs and simplifying
supplier management tools as needed.--------- --Engages in
Materials Management continuous improvements and efficiencies
including materials qualification, sampling processes and reduced
testing programs; supports client sourced materials/supplier
qualifications as needed. --Facilitates the process for movement of
client sourced materials into the Catalent Supplier Management
systems--------- --Continually evaluates systems and procedures for
improvement for efficiency while ensuring compliance to applicable
regulatory requirements and standards; creates and/or revises
procedures and tools associated with simplification of SQM policies
for Gene Therapy--------- --Other duties as assigned ----The
Candidate: ----------- --B.S. in a Life Sciences discipline and 10+
years of relevant GMP experience required, CMO/CDMO experience
preferred------- -- 2+ years Progressive Leadership experience,
experience with Performance Management, Goal Setting and Managing
through Conflict------- --Experience within SQM role preferred,
specifically in auditing and quality agreement negotiation highly
desirable; experience within the biologic, pharmaceutical or
medical device industry performing direct hands-on work in a
Quality Assurance/Quality Control function with a strong
familiarity with GMP Quality Systems and documentation; experience
with global Audit guidelines--------- --Experience with Good
Manufacturing Practices (GMPs) and 21 CFR part 11; ASQ CQA
(American Society of Quality Certified Quality Auditor) highly
desirable--------- --Experience within Quality Risk Management and
Risk assessments. --------- --Expert with electronic systems,
including TrackWise, and MasterControl and ability to create
queries and reports from these systems--------- --SME/Expert in all
Microsoft Applications i.e. --EXCEL, PowerPoint, Visio and
experience creating metrics --------- --Able to work in a team
setting and independently under minimum supervision; creative
individual with excellent trouble shooting skills; positive,
professional attitude toward work and willingness to cooperate with
co-workers and supervisors and to contribute to the corporate and
local teams; ability to succeed in a team-oriented environment
under very dynamic conditions; able to demonstrate understanding
and adherence to Catalent policies, safety procedures and the
cGMPs--Why you should join Catalent:------- --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---------
--Dynamic, fast-paced work environment------- --Generous 401K match
and Paid Time Off accrual--------- --Medical, dental and vision
benefits effective day one of employment--------- --Tuition
Reimbursement--------- --Wellhub 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.--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 , Manager, Supplier Quality, Professions , Severn, Virginia
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