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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 & Responsibilities
This position is responsible for all QA activities that directly support the execution of the process both within the Sterile Ops Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

• Maintain a high level of understanding of relevant production processes and quality systems.

• Perform the QA review and approval of the following GMP documentation that has a direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:

  • Change Requests

  • Batch Records and associated documentation

  • Product and Component Release transactions in SAP

  • Quality Investigations (Deviations, Product Complaints)

  • Validation Plans, Protocols and Reports

  • Standard Operating Procedures

• Accountable for disposition (release or rejection) of incoming materials, bulk product, and filling product.

• Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems.

• Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.

• Interface with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects.

• Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices.

• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders.

• Collaborate in data analysis and report creation on quality metrics and key performance indicators.

• Strong collaboration between other areas to ensure consistent application of quality systems/processes across the site.

• Ability to work independently with minimal guidance from management.

• Demonstrate a strong understanding of the technology area to which the individual is assigned

• Act as execution lead/process owner for one or more processes.

• Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.

• Demonstrate leadership capabilities.

• Train and mentor junior members of the QA organization and provide QA coaching to other non-QA employees within the area supported.

• Strong performance history of consistently meeting or exceeding expectations.

• Hold others accountable for high standards and clarify what needs to be accomplished, why, and the consequences for the individual and/or the organization.

• Accountable for some key business process metrics and team performance metrics.

• Responsible for developing and delivering training content in areas of expertise.

• Ownership for PET QA Batch Disposition business processes and key interactions with Operations, QC, Supply Chain, other PETs, and external stakeholders.

• SME for sterile operations and QA support for projects in projects in the PETs.

Minimum Qualifications

• Significant experience in either the pharmaceutical industry, an operations environment, or Quality Assurance

• Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment

• Excellent oral and written communication skills

• Strong ability and motivation to learn

• Strong problem-solving skills

• Ability to coach and mentor peers

Preferred Qualifications

• Bachelor's/master's degree in a science or technical field such as pharmacy, biology, chemistry, or engineering

• Previous experience in a Lean, process-centric organization with emphasis on continuous improvement

• Multi-site/multi-functional experience

• Considerable experience in Quality Assurance

• Experience with SAP, FMEA execution and upkeep, and pharmaceutical PQS

• Additional technical experience or background desired: Sterile Manufacturing - aseptic/sterile manufacturing, contamination control, EM

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.