Senior Specialist External Quality

Senior Specialist External Quality

Key Accountabilities:

• Ensure audit due dates for suppliers are maintained.
• Manage and provide guidance and/or assist in defining, implementing and follow-up for supplier audit reports and CAPA ensuring adequate corrective action is in place and monitoring the effectiveness of that action. 
• Development of a Supplier Quality management performance evaluation through Key Performance Indicators (KPI) and continuous improvement for the highest effectiveness of the supplier management system.
• Contribute to the development, maintenance and improvements of supplier management policies, standards and procedures.
• Participate in supplier development projects and continuous improvement activities focusing on supplier quality.
• Assist in Internal audits and ISO/FDA audits.
• Responsible for SAP Quality Module implementation (QM Views, inspection plans, AMPL)
• Responsible for overseeing Supplier related changes and implementation of required actions to address changes.
• Responsible for tracking Supplier quality on a monthly / quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions.
• Communicate to management quality and regulatory issues on a timely basis.
• Assist with development of the Approved Supplier List and areas to be targeted during the assessment or evaluation.
• Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits.

Essential Requirements:

• Bachelor's Degree in Biology, Biochemistry, Chemistry, Engineering or related fields
• 1+ years of supplier quality experience
• 7+ years of Quality experience
• Computer Skills: MS Outlook, MS Powerpoint, MS Excel, MS Word

Desired Requirements:

• Drug Substance and/or Drug Product experience
• Autologous, Allogenic, or In-vivo cell therapy experience
• Graduate degree in related field

The annual base pay (or hourly rate of compensation) for this position ranges from $100,880 to $151,321. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.