Supervisor, External Quality Assurance

Advancing medicine to save lives. Together. 

 

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.  

 

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.  

 

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. 

The Supervisor, External Quality Assurance Supervisor 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.

 

 

Duties and 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

Qualifications

• 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

Preferred Qualifications

• 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

Working Conditions

• Clean room environment
• Personal Protective Equipment must be worn as required
• Normal office working conditions: computer, phone, files, copier
• Will interact frequently with internal stakeholders, customers, and cross functional teams
• Pace may be fast and job completion demands may be high

Physical Requirements

• Frequent standing/walking to work in controlled environment for extended periods
• Frequent sitting for extended periods to use computer

Direct Reports

•  Position may have 1-4 direct reports of varying skill and experience levels