We are seeking a highly motivated individual to join us as a Sr. Manager, Quality Assurance within our Supplier Quality Management Department. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
This individual will work cross functionally to execute and improve the Supplier Quality Management (SQM) program that supports our rapid expansion to commercial manufacturing and first marketed product. Your responsibilities will include auditing, establishing and updating QTA’s, managing SCARs and coordinating assessment and implementation of supplier changes for raw material and component suppliers. This role will be a hands-on resource reporting to the Director, Quality Assurance (SQM-Materials).
Responsibilities (include but are not limited to):
- Assist in management and enhancement of supplier qualification process that will use risk-based tools for classification, qualification and monitoring.
- Perform audits of raw materials and component suppliers. Work with suppliers to identify and implement responses to observations. Write audit reports and close records within target timelines.
- Develop and review supplier Quality Agreements (in collaboration with Legal and Supply Chain) and establish a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed.
- Assist requestors with new specification development and manage the onboarding of new materials and suppliers.
- Assist in the management and execution of supplier change management system for raw materials and components.
- Own and/or approve change controls to manage new materials and material changes.
- Assist in maintaining the audit schedule and approved supplier list (Oracle Agile and EBS) for assigned suppliers.
- Act as Quality contact for supplier issues and discrepancies (SCARs), and lead/manage the investigations to resolve the issues.
- Participate in selection and qualification of new suppliers.
- Perform metrics monitoring and refine metrics as needed.
- Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
- Ability to travel up to 25%.
- Perform other duties as assigned.
- Bachelor’s degree and 8 years of experience or Masters and 6 years of experience in a scientific or technical field in a pharmaceutical or biologics supplier quality management role, or other quality role requiring performance of compliance audits. Biologics or vaccines experience preferred.
- Experience auditing suppliers for raw materials, sterile components, primary and secondary packaging components and sterilization facilities.
- ASQ Certified Quality Auditor preferred.
- Experience in identifying, writing, evaluating and closing investigations.
- Working knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178
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