Quality Senior Manager – Contamination Control Strategy

We are seeking an experienced Quality Senior Manager – Contamination Control Strategy to lead JEB's efforts in maintaining the highest standards of cleanliness and contamination control in our manufacturing processes. This role is critical in ensuring product quality, regulatory compliance, and operational excellence. This position is responsible for developing, implementing, and maintaining global standards as they relate to Contamination Control Strategy (CCS) at Just-Evotec Biologics.

Key Responsibilities:

• Coordinate and/or lead risk assessments (in alignment with Annex 1 EU and FDA Guidance) that include but are not limited to facility, utility, personnel, equipment, environmental monitoring, cleaning and sanitization, sterilization, bio-safety and decontamination, hazardous materials, warehousing and storage, new products, cell lines, pest control, raw materials, critical reagents, etc.
• Responsible for implementing, tracking and monitoring the progress of Contamination Control Program including implementation of contamination control systems and processes for NPI (new product introductions).
• Support sites in maintaining the highest level of environmental integrity and ensuring Just-Evotec maintains the required contamination controls to meet expected product microbial attributes.
• Provide support to the QC Microbiology groups on audits, inspections, change controls, environmental monitoring performance qualifications (EMPQ), client inquiries, risk assessments, facility changes, defend microbiology laboratory practices and low bioburden manufacturing practices etc.
• Interface with Manufacturing, Facilities, Technical Operations, QA, QC and Validations teams to leverage expertise and knowledge across multiple modalities.
• Support contamination characterization through in-house capabilities or outside testing services, including sample collection and analysis from cleanrooms and hardware, writing reports, and maintaining cleanliness associated equipment.
• Utilize quality risk management tools develop microbiological risk assessments for existing and prospective processes and evaluate overall facility microbial contamination control strategies.
• Provide technical support for facility and suite start-up and facility lifecycle management.
• Support product lifecycle management, including technology transfer, GMP manufacturing runs, and approval of viral vector products.
• Support the implementation of contamination control continuous learning and training programs to Just-Evotec staff.
• Participate and network in the external industry forums and/or conferences to implement regulatory requirements and industry best practices.
• Support internal aseptic process simulations (media fill) strategies.
• Support the Quality Management System for Microbiology and Contamination Control (deviations, CAPA, Change control, procedures, etc.)
• Support and contribute to trending analysis, control implementation, validation protocol design, management review and audit preparations.

Qualifications:

• BS in Microbiology, or related field with 8+ years relevant Quality experience and 10+ years’ experience in industry.
• Knowledge of relevant and current FDA, EU, USP, ICH Guidelines and regulations associated with contamination control.
• Previous experience working with non-conformances, and corrective action and preventive action processes.
• Experience writing and reviewing technical documentation.
• Influence management skills; ability to work constructively across all functions of the organization and build relationships.
• Experience with quality tools and process improvement techniques.
• Strong critical thinking and analytical skills.
• Strong critical thinking and analytical skills.
• Basic Statistical Knowledge and Application

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $112,560 to $154,100; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.