Director, Quality Systems
Company: Disability Solutions
Location: Severn
Posted on: April 17, 2024
Job Description:
POSITION SUMMARY The Director, Quality Systems is responsible
for the management and oversight of the core quality systems,
including investigation/deviation management, CAPA tracking, change
control, risk management, supplier quality, audits and inspections,
raw materials release, and compiling, trending and reporting key
quality metrics for Senior Management review, and other quality
system functions, as needed.The Role
- Provides strategic direction to the QA Systems staff supporting
Investigation/Deviation/ CAPA Management, Change Control, Risk
Management, Quality Metric Tracking responsibilities
- Ensure staff are fully trained on all cGMP manufacturing
operations and documentation and adhering to safety
guidelines----
- Build effective teams that apply their diverse skills and
perspectives to achieve common goals. Drive engagement and create a
culture where employees are motivated to do their best
- Oversee daily activity for the group to ensure quality results
Performance management for direct reports.
- Responsible for and administers Investigation and Deviation
systems for tracking statuses, follow-up, and liaison with
applicable department investigation writers to ensure their
complete and timely resolution
- Responsible for and administers the CAPA Tracking System for
general GMP use and internal audits. Track the timely completion
and extension of commitments
- Perform trending reviews of deviations and investigations,
compile reports and identify trends or areas requiring additional
actions
- Responsible for and administers the change control system for
tracking and coordinating the initiation, execution and completion
of change controls
- Responsible for and administers the Risk management system and
track completion of risk assessments
- Compile pertinent QA metrics for Senior Management review
- Assemble critical metrics from applicable departments, analyze
using appropriate tools to identify trends and report via a
PowerPoint presentation to be reviewed by Senior Management on a
periodic basis. Track action items for completion
- Support client projects and provide quality oversight of
manufacturing operations and the release of drug substance and/or
final drug product to support Phase I/II clinical trials
- Work with clients during initial and subsequent manufacturing
campaigns
- Maintain databases and systems used for tracking various GMP
manufacturing associated support activities
- Assists with the generation and/or revision of GMP
documentation such as standard operating procedures
- Manages regulatory (FDA, EMA) and client audits/inspections of
Catalent. Responsible --performing internal audits
- Work closely with other departments at Catalent and offer
assistance as needed
- Continually evaluate systems and procedures for improvement for
efficiency while ensuring compliance to applicable regulatory
requirements and standardsThe Candidate
- Bachelor's degree with 12-14 years or Masters' degree with
10-12 years in a Scientific, Engineering or Biotech field within
the biologic, pharmaceutical or medical device industry performing
direct hands-on work in a Quality Assurance/Quality Control
function with a strong familiarity of general GMP
documentation.
- 6 - 8 Progressive Leadership experience, experience with
Performance Management, Goal Setting and Managing through
Conflict.--
- ASQ CQA (American Society of Quality Certified Quality Auditor)
highly desirable
- Have the knowledge, and ability to apply basic scientific and
regulatory principles utilized to solve operational, as well as
routine quality tasks
- Experience with Good Manufacturing Practices (GMPs) and 21 CFR
Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR
Part 820
- Expert knowledge of biological regulations (21 CFR Part 600s)
or EU GPs, a plus
- Proficient with electronic systems, including developing and
producing reports.
- Experience with data analytics and concepts
- Ability to quickly learn and navigate new electronic
systems
- Able to work in a team setting and independently under minimum
supervision
- Ability to work in fast paced environment supporting the
quality assurance/quality control departments of a CMO for Phase
I/II/III GMP manufacturing of biologic bulk drug substance and
sterile finished drug product.
- Creative individual with excellent trouble shooting skills
- 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, Eldersburg , Director, Quality Systems, Executive , Severn, Maryland
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