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.
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Position Summary & Responsibilities
The Quality Assurance Manager will be accountable for all QA activities and decisions to directly support the workstreams across the site. These activities and decisions include batch release, change control, and documentation, equipment and process validation, deviation investigations, SOPs, and regulatory interactions and may also include incoming material inspection and release. This role will evolve to provide leadership, daily support, and supervision of GMP operations. The Quality Assurance Manager will develop quality on-the-floor programs to support GMP manufacturing, and the training of QA personnel, and also be responsible for overseeing the daily activities of QA staff.
Job 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)
Batch Release decisions and material disposition
Quality Investigations (Deviations, supplier deviations)
Validation Plans, Protocols, and other technical reports reports
Standard Operating Procedures & Risk Assessments
Accountable for the release of incoming materials (bulk, APIs, excipients, packaging components, and so on.)
Manage a team of up to approximately 10 -15 direct reports
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; ensurea 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 record 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
Minimum Qualifications
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 Qualifications
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
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 operations 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 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 $95,000.00 - $136,250.00 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.
RESILIENCE (National Resilience, Inc.), is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans
