Senior Manager, Quality Assurance

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 Senior Manager, Quality Assurance within the Process Execution Team (PET) is accountable for all QA activities and decisions that directly support the execution of the PET mission. These activities and decisions include batch release, change control, and documentation, equipment and process validation, deviation investigations, SOPs, regulatory interactions and may also include incoming material inspection and release. This leadership role, reporting to the Director, QA and the Manufacturing Director (indirectly), is the primary point of contact for all QA matters related to PET execution (quality, supply, and cost) and the primary link between the PET and other QA/QC functions.

Position 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 PET; works with the PET leaders and other PET members to deliver all PET objectives

• Provides 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 (OCM)

  • Batch Release decisions including Field Alert Assessments and Stop Shipments

  • Quality Investigations (Deviations, Product Complaints)

  • Validation Plans, Protocols and Reports

  • Standard Operating Procedures & Risk Assessments

• May be accountable for release of incoming materials (bulk, APIs, excipients, packaging components and so on.)

• Collaborates with Quality 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.

•  Provides support to internal audits and regulatory agency inspections for queries relating to process execution activities

• 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 PET objectives

• Serves as liaison in discussions and agreements with, and ensures timely communication to, other QA functions at the Site (Compliance and QC Labs)

• Serves as the liaison to Resilience supply sites and quality organizations; may also serve as QA representative to U.S. product supply teams

• Collaborates with other members of the PET to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices

• Participates on internal task forces and external industry associations that evolve and transform the quality assurance discipline

Minimum Qualifications:

• Significant experience in a leadership capacity

• Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies

• Advanced knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment

• Demonstrated ability to influence leaders in a matrix environment and the personal conviction to make courageous decisions to ensure patient safety and to protect company reputation

Preferred Qualifications:

• Bachelor’s degree in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering

• Advanced degree, Masters or higher

• Experience in supervisory/managerial roles within QA in the Pharmaceutical Industry

• Mul