Manager, Quality Assurance (Night Shift)
Company: Resilience
Location: West Chester
Posted on: October 30, 2025
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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 www.resilience.com
Position Summary The Manager, Quality Assurance (Night Shift) will
be accountable for all QA activities and decisions to directly
support GMPproduction operations in a Process Execution Team (PET).
These activities and decisions include change control, technology
transfer and project support, documentation, equipment and process
validation, deviation investigations, SOPs, and regulatory
interactions and may also include medical devicemanagement support.
This role will evolve to provide leadership, daily support, and
supervision of GMPoperations. The Quality Assurance Manager will
develop a quality support program for technical projectsprograms to
support GMP manufacturing, and the training of QA personnel, and
also be responsible foroverseeing the daily activities of QA staff.
This is a Night Shift position Position Responsibilities: Develops
and maintains a high level of understanding of the technical
production process andquality systems being utilized within the
Process Execution Team (PET) Accountable for all QA decision-making
in the PETs; works with the PET leaders and other teammembers to
deliver all PET and site objectives. Provide direction,
development, and performance management to the Quality
professionalssupporting the PET. Accountable for the QA review and
approval of the following GMP documentation that has adirect impact
on the activities performed by, and the equipment and facilities
utilized by the PET: Change Management (Change controls) Quality
Investigations (Deviations, supplier deviations) Support Technical
Transfers, Validation Plans, Protocols, and other technical
reports. Standard Operating Procedures & Risk Assessments Medical
device management and support Accountable for the release of
incoming materials (bulk, APIs, excipients, packaging components,
and so on.) Team management Support the site to ensure a safe
working environment, including leading your team's safetyefforts.
Supervise, coach, and assist with employee development and
performance management; ensure a fair and equitable workplace.
Collaborates with other managers and Quality professionals from
other PETs (including othersites) to ensure consistent application
of the key quality systems across all PETs. Interfaces with the
Site Support Groups on improvement projects (capital and
noncapital) thatimpact the PET, and proactively ensure GMP
compliance during the planning, execution, andcloseout phases of
these projects. Work cross-functionally with the area process teams
for metrics reviews, operational support, and issue/deviation
management. Ensures that PET complies with all GMP Compliance and
Regulatory requirements by providingproper coaching, mentoring, and
consultation to the PET leader and PET members. Ensures that the QA
processes including batch documentation review, product
disposition, andquality issues resolutions are executed to maintain
the flow of products and documents to meetorganization objectives.
Foster a strong quality culture including maintaining open
communications and promotingteamwork and employee participation in
the workgroup. Minimum Qualifications: Experience in a position of
people leadership Advanced knowledge of cGMP requirements, quality
systems, and sterile/aseptic manufacturing Ability to influence
leaders in a matrix environment, as well as the personal conviction
to make courageous decisions to ensure patient safety and safeguard
the company's reputation. Preferred Qualifications: Five years of
experience in supervisory/managerial roles within QA in the
Pharmaceuticalindustry Bachelor's Degree or Higher Multiple site or
functional experience Experience with medical device/sterile
manufacturing regulations Demonstrated problem-solving and
decision-making skills Ability to direct and participate in
cross-functional teams. Advanced knowledge of regulatory agency
interactions and compliance procedures, with theability to apply
the knowledge in an operation environment The 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 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 $95,000.00 - $143,750.00 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 , Manager, Quality Assurance (Night Shift), Science, Research & Development , West Chester, Ohio
