Senior Manager, Quality Assurance
Company: Resilience
Location: West Chester
Posted on: November 18, 2023
Job Description:
A career at Resilience is more than just a job - it's an
opportunity to change the future. Resilience is a
technology-focused biomanufacturing company that's changing the way
medicine is made. We're building a sustainable network of
high-tech, end-to-end manufacturing solutions to better withstand
disruptive events, serve scientific discovery, and reach those in
need.For more information, please visit Position Summary:The Senior
Manager, Quality Assurance within the Process Execution Team (PET)
is accountable for all QA activities and decisions that directly
support the execution of the PET mission. These activities and
decisions include batch release, change control, and documentation,
equipment and process validation, deviation investigations, SOPs,
regulatory interactions and may also include incoming material
inspection and release. This leadership role, reporting to the
Director, QA and the Manufacturing Director (indirectly), is the
primary point of contact for all QA matters related to PET
execution (quality, supply, and cost) and the primary link between
the PET and other QA/QC functions.Position Responsibilities:
- Develops and maintains a high level of understanding of the
technical production process and quality systems being utilized
within the Process Execution Team (PET)
- Accountable for all QA decision-making in the PET; works with
the PET leaders and other PET members to deliver all PET
objectives
- Provides direction, development, and performance management to
the Quality professionals supporting the PET.
- Accountable for the QA review and approval of the following GMP
documentation that has a direct impact on the activities performed
by, and the equipment and facilities utilized by the PET:
- Change Management (OCM)
- Batch Release decisions including Field Alert Assessments and
Stop Shipments
- Quality Investigations (Deviations, Product Complaints)
- Validation Plans, Protocols and Reports
- Standard Operating Procedures & Risk Assessments
- May be accountable for release of incoming materials (bulk,
APIs, excipients, packaging components and so on.)
- Collaborates with Quality Managers and Quality professionals
from other PETs (including other sites) to ensure consistent
application of the key quality systems across all PETs
- Interfaces with the Site Support Groups on improvement projects
(capital and noncapital) that impact the PET, and proactively
ensure GMP compliance during the planning, execution, and closeout
phases of these projects.
- Provides support to internal audits and regulatory agency
inspections for queries relating to process execution
activities
- Ensures that PET complies with all GMP Compliance and
Regulatory requirements by providing proper coaching, mentoring and
consultation to the PET leader and PET members
- Ensures that the QA processes including batch record review,
product disposition and quality issues resolutions are executed to
maintain the flow of products and documents to meet PET
objectives
- Serves as liaison in discussions and agreements with, and
ensures timely communication to, other QA functions at the Site
(Compliance and QC Labs)
- Serves as the liaison to Resilience supply sites and quality
organizations; may also serve as QA representative to U.S. product
supply teams
- Collaborates with other members of the PET to facilitate
process improvements and risk assessments; benchmarks internal and
external QA practices to identify innovative efficient and
effective practices
- Participates on internal task forces and external industry
associations that evolve and transform the quality assurance
disciplineMinimum Qualifications:
- Significant experience in a leadership capacity
- Advanced knowledge of cGMP requirements, quality systems, and
pharmaceutical manufacturing/packaging technologies
- Advanced knowledge of regulatory agency interactions and
compliance procedures, with ability to apply the knowledge in an
operations environment
- Demonstrated ability to influence leaders in a matrix
environment and the personal conviction to make courageous
decisions to ensure patient safety and to protect company
reputationPreferred Qualifications:
- Bachelor's degree in a science/technical field such as
Pharmacy, Biology, Chemistry or Engineering
- Advanced degree, Masters or higher
- Experience in supervisory/managerial roles within QA in the
Pharmaceutical Industry
- Multiple site or function experience
- Ability to direct and participate in cross-functional teamsThe
items described here are representative of those that must be met
successfully to perform the essential functions of this
job.Resilience is an Equal Employment Opportunity Employer.
Qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender perception or identity, national origin, age, marital
status, protected veteran status, disability status, physical or
mental disability, genetic information, or characteristic, or other
non-job-related characteristics or other prohibited grounds
specified in applicable federal, state, and local laws. Requests
for reasonable accommodation can be made at any stage of the
recruitment process.Resilience offers employees a robust total
rewards program including equity, an annual cash bonus program, a
401(k) plan with a generous company match and our benefits package
which is thoughtfully designed to support our employees with great
healthcare (including medical, dental and vision), family building
benefits, life and disability insurance, flexible time off, paid
holidays, other paid leaves of absence, tuition reimbursement and
support for caregiving needs. Our target base pay hiring range for
this position is $115,000.00 - $171,250.00 per year. Actual base
pay is dependent upon a number of factors, including but not
limited to, the candidate's geographical location, relevant
experience, qualifications, skills and knowledge. Excited about
Resilience and the biomanufacturing revolution? We encourage you to
apply and start a conversation with one of our recruiters.
Keywords: Resilience, Hamilton , Senior Manager, Quality Assurance, Executive , West Chester, Ohio
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