Supervisor, External Quality Assurance

Rentschler Biopharma•Milford, MA

5d•Onsite

About The Position

The Supervisor, External Quality Assurance will provide hands-on day-to-day leadership for the External Quality Assurance function in a fast paced, rapidly changing CDMO environment. This role is responsible for supervising personnel, setting priorities, coordinating workload, and ensuring that quality deliverables are executed in alignment with client expectations, internal procedures, and applicable regulatory requirements. The successful candidate will demonstrate sound judgment, accountability, strong communication skills, and the ability to balance tactical execution with longer-term process improvement. As part of the Quality Assurance team supporting a multi-product CDMO facility, the Supervisor, External Quality Assurance is responsible for identifying and assessing regulatory and quality risks associated with the production of biological drug substances and related quality systems. This position provides leadership and oversight for quality support of new product introduction, client-facing quality activities, document review and approval, inspection readiness, and continuous improvement initiatives. The Supervisor serves as a key escalation point for complex quality issues and partners cross-functionally to ensure compliance with regulatory agency requirements and company quality practices.

Requirements

Bachelor’s Degree in STEM or related discipline
7+ years of experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industry
Prior experience leading, mentoring, or coordinating the work of others in a quality environment
Strong knowledge of FDA cGMP regulatory requirements as they apply in a biologics manufacturing environment
Strong knowledge of manufacturing processes and the impact of deviations, changes, and quality events on product quality and compliance
Demonstrated ability to make sound, risk-based quality decisions and escalate issues appropriately
Experience in electronic quality systems including advanced data mining, reporting, and query building
Strong interpersonal skills, organizational skills, and attention to detail
Strong verbal and written communication skills with the ability to manage multiple priorities in a dynamic environment
Microsoft Office – Outlook, Word, Excel

Nice To Haves

Professional Quality certifications a plus (CQA, CQE, CQM, RABQSA)
Prior experience in an external quality role within a CDMO or biologics manufacturing environment is preferred
Experience supporting customer-facing quality activities, audits, and regulatory inspections
Experience with change control, deviation management, CAPA, and quality risk management is preferred
Advanced Excel and data analysis skills are a plus

Responsibilities

Supervise, coach, and develop External Quality Assurance personnel, including work assignment, training, performance feedback, and prioritization of departmental deliverables
Serve as the primary escalation point for complex quality issues within the function and ensure timely resolution of quality events, client requests, and cross-functional action items
Provide Quality oversight and act as a key point of contact between the QA organization and customers for assigned programs and quality matters
Represent the Quality organization on collaborative cross functional program teams and drive alignment on quality expectations, deliverables, and timelines
Review and approve documents, records, and reports related to new product introduction, including master batch records, specifications, protocols, reports, and associated quality documentation for compliance with client requirements, internal procedures, and regulatory expectations
Serve as a Subject Matter Expert for Quality support of new product introduction, technical transfers, and lifecycle quality activities
Lead or support the development, revision, review, and approval of Standard Operating Procedures and related quality system documents to ensure ongoing compliance with Corporate, Site, client, and regulatory requirements
Monitor quality metrics, identify trends, and drive continuous improvement initiatives to enhance compliance, effectiveness, and efficiency of quality systems and processes
Provide leadership for training within the function and ensure personnel are qualified and effective in relevant Quality and compliance responsibilities
Support inspection readiness activities and participate in client audits, regulatory inspections, and internal assessments, including timely and effective follow-up to observations and commitments
Assess the adequacy, logic, and effectiveness of quality systems and recommend improvements that strengthen compliance and business performance
Other duties, tasks or projects as assigned