Head of Quality - Maryland
Company: Disability Solutions
Location: Severn
Posted on: April 18, 2024
Job Description:
Position SummaryThe Head of Quality-Maryland is responsible for
setting the strategic direction, properly staffing, and maintaining
the Quality Management Systems (QMS) to ensure the site is
compliant with regulatory, Corporate, and customer requirements.
They are responsible for establishing and maintaining the site
metrics, management review, and building a Patient First culture at
the site. The Head of Quality-Maryland is responsible for Quality,
Validation and Quality Control and is the most responsible person
for batch disposition. The Head of Quality will provide project
guidance and support while working with customers to resolve
quality concerns as appropriate.The Role
- Serve as the site's primary contact (with both customers and
regulatory agencies) for the site Quality Unit. Develop and
implement Site Quality Plan, Quality Unit objectives and related
procedures.
- Maintain an effective Quality Management System (QMS) that
aligns with regulatory requirements/expectations.
- Interface with all other departments to ensure compliance with
cGMP.
- Monitor site compliance to FDA, EU and all other applicable
requirements.
- Analyze, resolve, or assist in solving compliance and customer
issues.
- Ensure regulatory and customer audits are managed successfully
and any responses are submitted in a timely manner.
- Prepare, approve, and manage Quality departmental budget.
- Approve or reject, starting materials, packaging materials, and
intermediate, finished products, and evaluate batch production
records.
- Ensure that all necessary QC testing is performed on
manufactured products.
- Ensure Quality approval of specifications, sampling
instructions, test methods and other Quality Control
procedures.
- Review and approve Site Annual Product Reviews.
- Ensure that required validation activities are completed.
- Responsible for ensuring the environmental monitoring and
control of the manufacturing environment and plant hygiene.
- Require approval and monitoring of suppliers of materials.
Ensure the proper designation and monitoring of storage conditions
for materials and products.
- Actively participate in ensuring business measures/metrics are
met (e.g. Customer service)
- Ensure that Document Control activities are compliant with FDA,
EU and other applicable requirements and that controlled documents
are maintained in an orderly manner to allow rapid retrieval when
required.
- Stay informed regarding industry trends, interpretation of
regulations and application to the site.
- Being part of the Site Leadership Team representing the QRA
function for the site and supporting site mission/strategyThe
Candidate
- Bachelor's degree in chemistry or closely related field (e.g.
natural sciences, engineering) is strongly preferred
- 10-12 years' directly related experience in pharmaceutical
fields including managerial roles
- Experience with sterile drug product manufacturing and drug
substance manufacturing is strongly preferred
- Experience leading a manufacturing site operation (e.g. Quality
Operations, QC Operations, Manufacturing) is strongly
preferred
- Extensive knowledge of Quality Assurance and Quality
Control
- Demonstrated expertise in effectively leading a sizeable
organization with multiple levels and shifts, consisting of at
least 100-150 employees.
- Knowledge of cGMP, ICH, and other non-US regulations /
guidelines; demonstrated experience applying them to both cGMP
manufacturing and/or QC lab environments
- Ability to bring projects to a timely completion using Catalent
systems
- 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 experienceWhy 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--
- GymPass program to promote overall physical wellness--
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categoriesCatalent
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, Eldersburg , Head of Quality - Maryland, Other , Severn, Maryland
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