Manager, Quality Assurance Compliance
Company: Disability Solutions
Location: Princeton
Posted on: April 18, 2024
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Job Description:
POSITION 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.In support of
Manufacturing schedule, the Manager, Quality Assurance Compliance
provides Quality Assurance guidance and oversight on Quality
Management Systems (QMS). --This includes supporting Electronic
Document Management System (EDMS) and reviewing executed GMP
documentation.--Position is 100% on site at our Princeton, NJ
facility and will be on 1st Shift Monday-Friday 8AM-5PM.Catalent
hires people with a passion to make a difference. Your expertise,
coupled with our advanced technologies and collaboration with
innovative pharmaceutical, biotech and healthcare companies, will
help bring life-enhancing products to the people you know and love.
Your talents, ideas and passion are essential to our mission; to
develop, manufacture and supply products that help people live
better, healthier lives.--The Role:------- --Lead team supporting
Quality Management Systems (QMS) with QA review and decisions on;
CAPAs, Change Controls, Customer Complaints, operational
deviations, and Self-Inspection as needed.--------- --Manage
facility's Document Archive.--------- --Manage Quality Assurance
portion of training documentation.--------- --Lead and support site
initiatives for Inspection Readiness, Quality Council and
KPIs------- --Lead the oversight to ensure alignment with Catalent
policies & standards.------- --Head administration role for
Electronic Document Management System (EDMS) at Princeton facility
as needed.--------- --Other duties as assignedThe Candidate:-------
--Bachelor's Degree required with a minimum of 7 years of relevant
industry experience in a GMP regulated environment. -- -----------
--5 - 7 years of experience in a Quality Assurance role within a
Manufacturing setting, experience in a GMP Manufacturing setting
required, clinical experience preferred.------- --2 - 4 Progressive
Leadership experience, experience with Performance Management, Goal
Setting and Managing through Conflict. --------- --Familiarity with
Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211,
biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU
GMPs.------- --Experience in supporting or leading quality
management review;--------- --Prior experience in managing KPIs
preferred; Prior experience in audit management preferred ---------
--Ability to work under tight and emerging deadlines; Fluent in
speaking and writing English.--------- --Highly organized with
attention to detail and possess strong written and verbal
communication. --Ability to work on cross functional teams.
--Ability to lead team discussions and facilitate
meetings.--------- --Potential for 5% travel to other sites
annually--While performing the duties of this job, the employee is
frequently required to stand; sit and talk or hear. The employee is
occasionally required to walk; use hands to finger, handle, or
feel; reach with hands and arms; climb or balance and stoop, kneel,
crouch, or crawl.--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---------
--19 days of PTO + 8 paid holidays------- --Employee Stock Purchase
Program------- --Tuition Reimbursement--------- --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, Levittown , Manager, Quality Assurance Compliance, Executive , Princeton, Pennsylvania
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