Senior Manager, Quality Control, Microbiology

Recipharm; United States; Sur place; USD 155 000 - 165 000; Plein temps

Résumé du poste

Recipharm Advanced Bio seeks a Senior Manager, QC Microbiology to lead microbiological QC activities across client programs and manufacturing operations. You will ensure accurate testing, timely results, and strict data integrity in a GMP environment.

The role partners with QA, Manufacturing, Analytical Development, Validation, Regulatory Affairs, and Project Management to support development through commercial manufacturing, investigations, and continuous improvement in a fast-paced CDMO

Qualifications

• Bachelor's degree in Microbiology or related field is required.
• Minimum 8 years in GMP-regulated pharma/biotech environments.
• Supervisory or management experience in QC Microbiology.

Responsabilités

• Lead day-to-day QC Microbiology operations for multiple programs.
• Oversee testing of raw materials, in-process and finished products; environmental monitoring.
• Manage EMPQ, utilities testing, and trend reviews for contamination risks.
• Lead investigations (OOS/OOT), CAPAs, and change controls with cross‑functional teams.
• Maintain GMP compliance and data integrity across documentation.

Connaissances

GMP microbiology

Leadership

Environmental monitoring

Investigations

Data integrity

Documentation

Communication

Problem solving

Formation

Bachelor's in Microbiology

Master's preferred

Description du poste

Senior Manager, Quality Control, Microbiology

Recipharm Advanced Bio is seeking an experienced and highly motivated Senior Manager, Quality Control (QC) Microbiology to lead microbiological quality control activities supporting multiple client programs, products, and manufacturing operations. This role provides both technical and operational leadership for QC Microbiology, ensuring laboratory testing is performed accurately, efficiently, and in compliance with GMP regulations, approved procedures, client expectations, and applicable regulatory requirements.

The Senior Manager will partner closely with Quality Assurance, Manufacturing, Analytical Development, Process Development, Validation, Engineering, Regulatory Affairs, and Project Management teams to support programs from development and technology transfer through clinical and commercial manufacturing. The ideal candidate will possess strong microbiology expertise, proven leadership experience, excellent problem-solving skills, and the ability to manage competing priorities in a fast-paced CDMO environment.

QC Microbiology Operations

• Lead day-to-day operations of the QC Microbiology laboratory supporting multiple client programs and manufacturing activities.
• Ensure timely execution, review, and approval of microbiological testing for raw materials, in-process samples, finished products, stability programs, environmental monitoring, water systems, and manufacturing support activities.
• Establish laboratory priorities and allocate resources to meet manufacturing schedules, client commitments, and regulatory requirements.
• Monitor laboratory performance, workload, staffing, capacity, and turnaround times.
• Ensure testing is conducted in accordance with GMP requirements, approved procedures, specifications, protocols, and methods.
• Identify and resolve operational challenges that may impact laboratory performance, manufacturing timelines, or client deliverables.

Environmental Monitoring & Manufacturing Support

• Provide oversight of environmental monitoring programs supporting GMP manufacturing operations.
• Author and oversee Environmental Monitoring Performance Qualifications (EMPQ) as required.
• Manage microbiological testing of water systems, clean utilities, and manufacturing support systems.
• Review environmental monitoring and utility data to identify trends, excursions, and potential contamination risks.
• Author quarterly Environmental Monitoring and Utility Trend Reports.
• Support Aseptic Process Simulations (Media Fills).
• Provide microbiological expertise during investigations involving contamination events, environmental monitoring excursions, bioburden concerns, sterility issues, and related quality events.
• Collaborate with Manufacturing, Quality Assurance, Engineering, and Validation teams to determine root causes and implement effective corrective and preventive actions.

Quality Systems & Investigations

• Lead investigations related to OOS, OOT, deviations, laboratory errors, environmental monitoring excursions, and microbiological quality events.
• Ensure investigations are scientifically sound, appropriately documented, and completed within established timelines.
• Review and approve investigation reports, laboratory assessments, and associated documentation.
• Support CAPA, change control, risk assessment, and continuous improvement initiatives.
• Escalate quality risks that may impact product quality, manufacturing operations, regulatory compliance, or client commitments.

GMP & Regulatory Compliance

• Ensure QC Microbiology activities remain compliant with GMP regulations, company procedures, client requirements, and industry standards.
• Maintain a state of continuous inspection and audit readiness.
• Support client audits, regulatory inspections, internal audits, and quality assessments.
• Provide technical responses to audit observations and support implementation of corrective actions.
• Ensure laboratory documentation meets data integrity and ALCOA+ requirements.
• Maintain current knowledge of USP, EP, JP, FDA, EMA, and other relevant regulatory expectations and industry best practices.

Leadership & Staff Development

• Lead, mentor, and develop QC Microbiology personnel.
• Foster a culture of quality, compliance, accountability, and continuous improvement.
• Support hiring, onboarding, performance management, training, and professional development of laboratory staff.
• Promote effective cross-functional collaboration and communication across departments.

Education, Experience & Skills

Education

• Bachelor's degree in Microbiology, Biology, or a related scientific discipline required.
• Master's degree in Microbiology, Biology, or related field preferred.

Experience

• Minimum of 8 years of experience in pharmaceutical, biotechnology, CDMO, or other GMP-regulated environments.
• Previous supervisory or management experience within a QC Microbiology function.
• Experience supporting clinical and/or commercial manufacturing operations.
• Strong experience with environmental monitoring programs, microbiological testing, and sterility assurance.
• Experience leading investigations including OOS, OOT, deviations, CAPAs, and change controls.
• Experience with microbiological method transfer, validation, verification, and implementation.
• Experience supporting regulatory inspections and client audits.

Skills

• Strong knowledge of GMP microbiology laboratory operations and regulatory requirements.
• Comprehensive understanding of environmental monitoring, utility monitoring, contamination control, and aseptic processing.
• Strong sterility assurance background.
• Excellent technical writing, documentation review, and investigation skills.
• Strong understanding of data integrity principles and GMP documentation practices.
• Demonstrated ability to lead teams, influence cross-functional stakeholders, and manage competing priorities.
• Strong analytical, organizational, and problem-solving abilities.
• Excellent verbal and written communication skills.

Physical Demands

The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

While performing the duties of this position, the employee is frequently required to sit, stand, use hands to handle or feel objects, equipment, or controls, reach with hands and arms, and communicate effectively through speaking and hearing.

The employee is occasionally required to walk, climb or balance, and stoop, kneel, crouch, or crawl.

The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Specific vision abilities required for this role include close vision, color vision, depth perception, and the ability to adjust focus when reviewing laboratory data, testing results, and electronic records.

The position requires the ability to work in both office and laboratory environments, including GMP-controlled and classified manufacturing areas, while wearing appropriate personal protective equipment (PPE) and cleanroom gowning as required.

The employee will be required to communicate regularly via telephone, email, video conferencing, and other electronic communication platforms.

Regular use of computer systems and laboratory equipment is required.

No routine travel is required for this position.

The employee must be able to maintain compliance with all applicable safety, environmental, and quality requirements while performing assigned duties.

Annual Base Salary Range: $155,000 to $165,000

Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies.

It operates development and manufacturing facilities in France, Germany, India, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.

For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com