Principal, Compliance and Supplier Quality

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 Position Summary: Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We just started an incredible journey and are looking for passionate leaders to join us on this important mission. This role provides assistance for the quality oversight for suppliers/vendors used to manufacture, package and test Resilience clinical and commercial products in accordance with Resilience policies, standards, procedures and international cGMPs. The individual will assist with the review and will be responsible for the coordination and processing of supplier deviations and supplier change notifications as well as various other supplier quality activities related to raw material, consumable, external labs, transportation suppliers and more used for the manufacture, package and testing of products manufactured by Resilience on behalf of its clients. The individual will also have responsibilities that include but are not limited to providing quality support to Resilience stakeholders and SMEs, authoring/revising quality system documents as assigned. The Principal, Compliance and Supplier Quality is a key Supplier Quality role and reports to the Sr. Director of Compliance and Supplier Quality. The position will be physically located in the Norriton, PA (Philadelphia) area and will ensure a close partnership with Site Quality teams in the management and oversight of GMP Suppliers and Service Providers. Position Responsibilities: Accountable for establishing the requirements and implementing a robust, risk-based program for qualifying suppliers and contract service providers in support of GXP operations across the entire Resilience network Contributes to the development and implementation of the GXP supplier and service provider selection process Responsible for developing and managing the Approved Supplier List (ASL). Partners with stakeholders and contributes to the configuration and implementation of the electronic system for maintaining the ASL. Partners with stakeholders and develops templates for Quality Agreements. Manages the development and execution of Quality Agreements with suppliers and service providers. Acts as subject matter expert for supplier qualification during Client audits and regulatory inspections Collaborates with Procurement and Supply Chain partners to assure a compliant and agile Purchasing Control program Participates in periodic Supplier Review Board meetings. Ensures supplier qualification status is aligned with the business needs and supplier's overall performance. Develops plans and oversees the integration of supplier management programs from acquired businesses/organizations into Resilience's Supplier Qualification Program. Develops and manages departmental goals and corresponding budget in alignment with corporate vision and goals Recruits talent, mentors and coaches personnel Oversight of 3rd party suppliers including: Supplier Change Notifications - ensure internal documentation and impact assessment of supplier communicated change following internal policies and procedures. Ensure associated quality agreements are current and not affected by proposed change. Resilience Change Management activities - provide Supplier Quality impact assessment as required based on internally driven changes to GMP services, processes, materials, etc. Complete assigned change actions as required. Supplier Quality Events - ensure supplier notified deviations/OOS events are reported, investigated and closed out per internal policies and procedures. Engage with cross functional SMEs to ensure on time assessment, closure and remediation of reported supplier events Quality Agreement negotiation and approval Metrics / data analysis - develop and monitor supplier non-conformance data to identify systemic issues and facilitate remediation activities Quality Risk Assessment - support material and supplier risk assessments as requested Material Specification Approvals - provide Supplier QA approval for material specifications in alignment with internal processes and procedures Oversight of 3rd party CDMOs involved in aseptic filling Minimum Qualifications: Significant experience in Supplier Quality Oversight including creating and improving related processes and development and execution of Quality Agreements with suppliers and service providers. Strong knowledge of cGMP in the Pharma/Biotech industry to include FDA, EU, JP regulatory requirements as well as ICH/ISO guidelines. Comprehensive knowledge of global GMP regulatory requirements for aseptic filling, biologics, and cell & gene therapy products. Knowledge of aseptic and sterile product manufacturing processes and testing. Thorough knowledge of and competence in core quality processes such as change control, deviations/OOS, CAPA, and complaints. Experience as a supplier qualification subject matter expert during regulatory inspections. Excellent investigational and QA problem solving skills - e.g. Ability to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy. Ability to critically review investigations, interpret results and generate compliant conclusions consistent with Quality risk management principles. Demonstrate an analytical mindset - e.g. Able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures. Able to recognize supplier quality risks and develop contingency plans. Able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors. Able to author resulting procedures, documents, and tools as applicable. Able to recognize patterns in reported data and communicate strategic solutions to stakeholders cross functionally. Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders. Demonstrated skill in planning, organizing, and conflict management. Ability to travel domestically and internationally. Preferred Qualifications: Bachelor's degree or higher in Life Sciences, Chemistry, Engineering, or related field Minimum of 10 years of pharmaceutical industry experience, with minimum of 5 years in a Supplier Quality management role Experience in biotechnology industry 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 $145,000.00 - $216,250.00 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.

Created: 2024-11-11