Vice President, Quality - Maryland
Company: Disability Solutions
Location: Severn
Posted on: October 19, 2024
Job Description:
Vice President, Quality - MarylandPosition 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.-----The Vice President, Quality is a key leadership
position, who is accountable for ensuring the successful delivery
of quality and regulatory strategy and operational performance for
the Maryland campus.-- The Vice President, Quality is responsible
for establishing and staffing the Quality Unit to ensure the
organizational structure, talent, bench strength, and staffing is
effective in delivering the expected outcomes, in the right way,
for SQDC and strategic growth plans. This position reports directly
to the Senior Vice President of Quality & Regulatory Affairs and
will have strong working relationships with VP General Manager
Maryland and other Site Leadership team members.-- Working with and
leveraging the entire Global Catalent network, the position
executes on growth strategies, leading quality-related aspects of
the transition into commercial manufacturing and delivers on the
expected quality culture for the manufacturing sites.----The VP of
Quality is a key member of the BioProduct leadership team,
responsible for promoting a Patient First culture and ensuring
quality standards across the campus. They oversee Site Quality
Directors/Senior Directors, maintain customer relationships, and
address performance issues. The VP of Quality holds ultimate
responsibility for site quality, compliance, and operational
performance, including regulatory inspections and deviations. They
also manage the budget and sourcing of the Quality Unit to meet
business requirements. As a member of the Catalent Senior
Leadership Team, they provide impactful leadership.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
- Partner effectively with other functional leaders (Product
Development, Operations, etc.) and Site General Manager to develop
and maintain a meaningful and robust Quality and Patient First and
Quality culture across all aspects of the business.
- Champion, through clear and visible advocacy, Catalent's
Quality Management System (QMS), and ensure strong technical and
leadership capability at all levels of the Quality
organization.
- Responsibility for ensuring the site Quality leadership teams
(150-400 HC) is staffed with high caliber Quality leaders and
professionals, driving strong and effective performance culture at
all levels across the sites, and creating a strong succession
pipeline for key leadership roles.
- Define activity-based cost models and establish and execute a
budget that is in-line with the requirements of the business to
deliver on the testing, release and QMS commensurate with the needs
of the business to operate effectively and efficiently.
- Ensure appropriate metrics and reporting/escalation processes
are in place and being utilized to drive and improve required
operational execution and performance levels and drive appropriate
corrective actions planning when needed.
- Drive actions and remediation as required to meet the quality
performance and standards sets for the site.
- Drive execution and outcomes on critical deviations provide
clear direction and oversight including the review and approval of
the deviations as well as effective CAPA plans
- Development of strong customer relationships, partnering with
other Catalent leaders to establish outstanding performance and
customer impact that acts as a true competitive differentiator.The
Candidate
- Bachelor's or Master's Degree in science, pharmacy or related
discipline is required. MBA or PhD as educational background is an
advantage
- 10+ years' experience in biologics is a requirement. Experience
in managing a multi-site quality function in Biologics or Vaccines
is required. (minimum of 100+ quality employees overseen)
- Knowledge of global cGMP regulations including FDA, EMA,
ANVISA, and other Tier 1 regulatory agencies.
- Proven critical thinking aptitude in a demanding and fast paced
environment.
- Possesses visionary leadership; ability to identify new trends
in the quality and regulatory landscape, allowing Catalent to lead
the industry.
- Proven experience in driving substantial improvements of
quality performance across a broad range of initiatives including
development and recruitment of talent, process improvements,
elimination of exceptions/SOP standardization.
- Demonstrated success in executing multiple major quality
initiatives (such as: implementation of IT systems, upgrading plant
regulatory status, commissioning new plant operation, etc.).
- Provides reliable / defendable interpretations of regulatory
guidance for the customer and is capable of defending these
positions to regulatory agencies.
- 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 experience.Pay The anticipated
salary range for this position in Maryland is $265,000 - $365,000
plus variable incentive 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, Centreville , Vice President, Quality - Maryland, Executive , Severn, Virginia
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