Supervisor, External Quality Assurance

Rentschler Biopharma SE; Milford (MA); Vor Ort; USD 120.000 - 165.000; Vollzeit

Zusammenfassung

Rentschler Biopharma SE in Milford, MA is seeking an External Quality Assurance Supervisor to lead the QA function in a fast-paced CDMO setting. You will supervise personnel, escalate quality issues, and coordinate with clients to ensure compliance with regulatory requirements and internal procedures.

The role requires deep knowledge of FDA cGMP, QA systems, and readiness for client audits. Strong leadership, communication, and problem-solving skills are essential for continuous improvement

Qualifikationen

• Bachelor’s Degree in STEM or related discipline is required.
• 7+ years of experience in the Quality function within a biotech or pharmaceutical company or other regulated industry.
• Experience leading, mentoring, or coordinating others in a quality environment.
• Strong knowledge of FDA cGMP regulatory requirements in biologics manufacturing.
• Experience with electronic quality systems including data mining, reporting, and query building.

Aufgaben

• Supervise External Quality Assurance personnel, assign work, train, and prioritize deliverables.
• Serve as escalation point for complex quality issues and ensure timely resolutions.
• Provide QA oversight and act as liaison between QA and clients for programs and quality matters.
• Review and approve quality documents and records for compliance with client requirements and regulatory expectations.
• Support inspection readiness activities and participate in client audits and regulatory inspections.

Kenntnisse

Quality leadership

Risk-based decision making

Communication skills

Data analysis

Attention to detail

Cross-functional collaboration

Ausbildung

Bachelor’s Degree in STEM or related discipline

Tools

Excel

Electronic quality systems

CAPA software

Jobbeschreibung

locationsMilford, MA, United Statestime typeVollzeitposted onVor 6 Tagen ausgeschriebenjob requisition idJR2851Advancing 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 ResponsibilitiesSupervise, coach, and develop External Quality Assurance personnel, including work assignment, training, performance feedback, and prioritization of departmental deliverablesServe 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 itemsProvide Quality oversight and act as a key point of contact between the QA organization and customers for assigned programs and quality mattersRepresent the Quality organization on collaborative cross functional program teams and drive alignment on quality expectations, deliverables, and timelinesReview 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 expectationsServe as a Subject Matter Expert for Quality support of new product introduction, technical transfers, and lifecycle quality activitiesLead 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 requirementsMonitor quality metrics, identify trends, and drive continuous improvement initiatives to enhance compliance, effectiveness, and efficiency of quality systems and processesProvide leadership for training within the function and ensure personnel are qualified and effective in relevant Quality and compliance responsibilitiesSupport inspection readiness activities and participate in client audits, regulatory inspections, and internal assessments, including timely and effective follow-up to observations and commitmentsAssess the adequacy, logic, and effectiveness of quality systems and recommend improvements that strengthen compliance and business performanceOther duties, tasks or projects as assignedQualificationsBachelor’s Degree in STEM or related discipline7+ years of experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industryPrior experience leading, mentoring, or coordinating the work of others in a quality environmentStrong knowledge of FDA cGMP regulatory requirements as they apply in a biologics manufacturing environmentStrong knowledge of manufacturing processes and the impact of deviations, changes, and quality events on product quality and complianceDemonstrated ability to make sound, risk-based quality decisions and escalate issues appropriatelyExperience in electronic quality systems including advanced data mining, reporting, and query buildingStrong interpersonal skills, organizational skills, and attention to detailStrong verbal and written communication skills with the ability to manage multiple priorities in a dynamic environmentMicrosoft Office – Outlook, Word, ExcelPreferred QualificationsProfessional Quality certifications a plus (CQA, CQE, CQM, RABQSA)Prior experience in an external quality role within a CDMO or biologics manufacturing environment is preferredExperience supporting customer-facing quality activities, audits, and regulatory inspectionsExperience with change control, deviation management, CAPA, and quality risk management is preferredAdvanced Excel and data analysis skills are a plusWorking ConditionsClean room environmentPersonal Protective Equipment must be worn as requiredNormal office working conditions: computer, phone, files, copierWill interact frequently with internal stakeholders, customers, and cross functional teamsPace may be fast and job completion demands may be highPhysical RequirementsFrequent standing/walking to work in controlled environment for extended periodsFrequent sitting for extended periods to use computerDirect Reports Position may have 1-4 direct reports of varying skill and experience levelsBrauchen Sie Hilfe?Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team: [e-mail]