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Head Of Material And Supplier Quality

Company

Resilience

Address , , Nc
Employment type FULL_TIME
Salary $225,000 - $281,250 a year
Expires 2023-06-13
Posted at 1 year ago
Job Description
General Company Description
Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives. For more information, visit
www.resilience.com
.
Position Summary & Role
This role is accountable for the development, implementation, and lifecycle management of the Supplier Quality program. The Senior Director, Material and Supplier Quality, is in a critical leadership role and reports to the Chief Quality Officer. The position will be remote.
Job Responsibilities
  • Recruits talent and build high-performance team; mentors and coaches personnel
  • Ensures the approved supplier and service providers list is maintained and up-to-date.
  • Develops and manages departmental goals in alignment with corporate vision and goals
  • Ensures audits are conducted periodically, and any corrective and preventive actions are timely and satisfactorily completed by suppliers and service providers.
  • Accountable for verifying the material supplier and service provider’s compliance with corresponding regulatory requirements and applicable Resilience standards defined in the Quality Agreements and/or Business Agreements.
  • Collaborates with Procurement and Supply Chain partners to ensure a compliant and agile Purchasing Control program
  • Accountable for managing supplier-related corrective and preventive actions. Collaborates with stakeholders across all manufacturing sites and ensures timely responses/actions are received/implemented by suppliers in support of internal quality event investigations (deviations, product complaints, etc.).
  • Oversees the development and execution of Quality Agreements with suppliers and service providers to ensure key quality and compliance expectations are reflected in their operations
  • Supports inspection readiness plans and interacts with regulatory agencies during inspections on supplier quality-related matters
  • Accountable for managing the supplier notification/change control program
  • Partners with Supply Chain peers and co-chairs the Supplier Review Board. Ensures critical quality and compliance metrics are reviewed regularly, and any unfavorable trends are timely mitigated.
  • Oversees the development, implementation, and maintenance of policies, processes, and procedures for supplier and service provider qualification
Preferred Experience, Education & Qualifications
  • Comprehensive knowledge of global GMP regulatory requirements for biologics and cell & gene therapy products
  • Demonstrated ability to perform long-term project planning, team building, budgeting, and operational excellence
  • Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
  • Ability to travel
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
  • Excellent oral and written communication skills with strong technical writing experience required
  • Hands-on experience with managing Supplier Quality programs, including conducting audits, developing and negotiating Quality Agreements, managing supplier-related change control and corrective and preventive actions programs
Minimum Qualifications
  • Minimum of 12 years of pharmaceutical industry experience, with a minimum of 7 years in a Quality leadership role; experience in the biotechnology industry preferred
  • Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or a related field
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 annualized base pay hiring range for this position is $225,000.00 - $281,250.00. 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.