Resilience · 3 days ago
Manager, Quality Assurance
West Chester, OH
Full-time
Onsite
Mid, Senior Level
$95K/yr - $144K/yr
5+ years expResilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Manager, Quality Assurance will be accountable for all QA activities and decisions to support GMP production operations, including documentation, validation, deviation investigations, and training of QA personnel.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
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 PETs; works with the PET leaders and other team members to deliver all PET and site objectives
Provide 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 (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 safety efforts
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 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
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 providing proper coaching, mentoring, and consultation to the PET leader and PET members
Ensures that the QA processes including batch documentation review, product disposition, and quality issues resolutions are executed to maintain the flow of products and documents to meet organization objectives
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the workgroup
Qualification
Required
Experience in a position of people leadership
Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies
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
Five years of experience in supervisory/managerial roles within QA in the Pharmaceutical Industry
Advanced degree, bachelor's degree or higher
Multiple site or functional experience
Experience with medical device 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 the ability to apply the knowledge in an operation environment
Benefits
Annual cash bonus program
401(k) plan with a generous company match
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
Support for caregiving needs
Company
Resilience
Resilience is a biomanufacturing company that provides access to complex medicines and protects biopharmaceutical supply chains.
1001-5000 employees
H1B Sponsorship
Resilience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (6)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
$3.36BKey Investors
Oak Hill AdvisorsAdministration for Strategic Preparedness and ResponseMubadala
2025-10-29Debt Financing· $825M
2024-10-03Grant· $17.5M
2023-03-24Debt Financing· $410M
Leadership Team
William Marth
President & Chief Executive Officer
Susan Billings
Chief Commercial Officer (CCO)
Recent News
Help Net Security
2025-11-11
2025-11-05
Company data provided by crunchbase