Manager, Quality Assurance (Night Shift)

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.