Director, Quality Systems
Company: Disability Solutions
Location: Bloomington
Posted on: April 19, 2024
Job Description:
The Director of Quality Systems is responsible for managing
pharmaceutical quality systems governance. Reporting to the VP of
Quality, the Director of Quality Systems will manage all quality
systems, governance and continuous improvement as it relates to
Quality Management Systems for execution of contract development
and manufacturing operations on behalf of Catalent Indiana's client
base.The Role
- Director is responsible for providing leadership and strategic
direction in the development, implementation, and maintenance and
governance of quality systems and documentation, as well as other
process improvement initiatives, in compliance with GxP
regulations
- A successful candidate will possess a strong background in
regulatory compliance, expertise in quality management systems and
document control processes, attention to detail, and the ability to
collaborate cross-functionally and communicate effectively
- Provide leadership and daily management of the quality systems,
document control function, and supplier quality functions ensuring
alignment with company goals and objectives
- Support GxP functions by developing and implementing policies,
procedures, and processes to ensure compliance with regulatory
requirements
- Provide leadership and guidance to staff, promoting a culture
of quality and compliance throughout the organization, be a role
model for doing the right thing and delivery of quality at the
speed of business, and strong analytical and influencing skills as
a member of the Site Quality Leadership Team
- Responsible for QA oversight for health, use and control for
management and use of the electronic Quality Management systems at
Site
- Collaborate with cross-functional teams to ensure the
successful quality initiatives and integration of quality systems,
and documentation into all aspects of the organization.
- Conduct risk assessments and gap analyses to identify areas for
improvement in quality systems and documentation practices
- Monitor the performance of the quality management system
through the use of key performance indicators (KPIs), metrics,
effectiveness checks, and management review to identify trends and
areas for improvement
- Host the Quality Management Review, and establish and measure
associated metrics, for the holistic governance and documentation
of quality oversight
- Responsible for the management of audits (internal and client)
and regulatory inspections, commitments, and risk management
- Provide support during Client and Internal audits and
regulatory authority inspections.
- Develop and implement programs to improve internal quality
systems. Foster continuous improvement efforts and culture
- Manage a large quality team
- Define department goals and metrics
- Manage department contract negotiation and review for vendors
and contract staffThe Candidate
- Bachelor's degree in chemistry, organic chemistry,
biochemistry, or other relevant scientific discipline, or above 20
years relevant Quality experience in Pharmaceutical including
demonstrated success at Senior Quality leadership level; advanced
degree preferred
- 10+ years of QA experience in the pharmaceutical industry or a
combination of pharmaceutical and other related FDA/EU regulated
industry
- Experience with a range of dosage forms, including biologics,
liquid sterile, and lyophilized product
- Demonstrated experience in selecting, implementing, and
managing electronic Quality Management Systems
- Knowledge of GxP regulations, with prior experience supporting
GMP operations (e.g. reviewing batch records, managing quality
events)
- Strong leadership and management skills, with the ability to
inspire and motivate cross-functional teams
- Excellent communication and interpersonal skills, with the
ability to effectively interact with stakeholders at all levels of
the organization
- Strong analytical and problem-solving skills, with the ability
to identify and address complex issues in a timely manner
- Ability to thrive in a fast-paced and dynamic environment, with
a commitment to continuous improvement
- Progressive management experience in pharmaceutical quality,
ultimately leading a quality team of significant size
- ASQ certification preferred
- Six Sigma
- GMP QA experience
- A depth of FDA-facing experience in managing both internal
audits and external audits and inspection
- A track record of accomplishment in managing multiple competing
priorities on tight timelines
- 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.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--
- 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, Bloomington , Director, Quality Systems, Executive , Bloomington, Indiana
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