Senior Manager, Quality Assurance Data Integrity Compliance
Company: Disability Solutions
Location: Severn
Posted on: October 24, 2024
Job Description:
The Senior Manager, Quality Assurance Data Integrity Compliance
performs evaluation of internal controls, communications, risk
assessments and maintenance of documentation as related to
compliance with internal and external safety, quality, and
regulatory standards. Identifies risk and evaluates deficiencies
while working with internal departments/business units to
appropriately remedy them.Supports internal training on quality
assurance/data integrity requirements, processes, and procedures.
Supports the organization with responsibility for creating training
materials, delivery of training to staff, proactively fostering a
culture of Data Integrity, and resolving Data Management
issues.Maintains the site Data Integrity Compliance plan and
provides quarterly updates to senior leadership team to determine
appropriate actions to be taken to ensure ongoing compliance with
Catalent and Regulatory expectations.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. 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:
- Assures compliance with cGMP regulations, Catalent standards,
and applicable regulatory requirements.
- Resolves Quality Assurance issues complex in scope following
cGMP regulations and Catalent standards.
- Drives improvement of processes of the quality system.
- Authors, revises, reviews, and approves controlled documents in
compliance with cGMP regulations.
- Performs assigned tasks and work to achieve company goals and
department objectives.
- Tracks and/or manages Corrective and Preventative Action (CAPA)
actions as they apply to Data Integrity Compliance.
- Assists in customer and/or regulatory audits.
- Establishes and chairs the Data Integrity Governance Team
meetings.
- Provides assessments and status updates to aid Data Integrity
Governance team's actions to maintain and proactively improve data
integrity.The candidate:
- Bachelors Degree in Science or related field required
(Chemistry, Microbiology or Biology preferred)
- 5+ years of relevant work experience in pharmaceuticals,
preferably biotechnology within a Quality role
- Solid knowledge of current Good Manufacturing Practices (cGMP)
and current Good Documentation Practices (cGDP).
- Experience in data review, 21 CFR Part 11 instrumentation
compliance.
- Knowledgeable in Quality Management Systems (FDA or ICH
approach to risk management and QMS). Demonstrated ability to write
and provide a thorough QA technical review of root cause
investigations, OOS, and complaints.
- Ability to audit GxP processes and Quality Management
Systems.
- Experience with review of CAPA reports, Master Batch Records,
SOPs, change control, validation protocols and reports, QA
agreements, and audit reports.The anticipated salary range for this
position in Maryland is $152,800-$210,000 plus an annual bonus
target.--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:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
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, Ellicott City , Senior Manager, Quality Assurance Data Integrity Compliance, Executive , Severn, Maryland
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