Manager, Quality Control

 

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

As Quality Control Manager (Microbiology) you will be accountable for management of a GMP Quality Control Microbiology and Environmental Monitoring department supporting microbiological testing of APIs according ICH Q7 and 21CFR regulations; oversee the Quality Control activities associated with microbiological method validation and transfer; testing of product; Environmental monitoring; training on aseptic technique and test methods; OOS/OOT investigations; deviation and CAPA management.

 

• Management and development of Quality Control microbiology department, consisting of 2 groups totaling 20+employees.
• Accountable to meet business and quality performance metrics through continuous process improvement initiatives.
• Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity.
• Detect quality problems w/in the department, prepare investigation reports, and implement corrective actions in a timely manner. Manage test deviation as necessary with QA and notify it to management.
• Collaborate cross functionally as needed to ensure the Quality Management System processes are implemented in accordance with established procedures.
• Attend project team meetings as the QC microbiology representative and works closely with the team to ensure on-time delivery.
• Interface with internal and external customers on a regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes.
• Develop and manage the department budget and capital expenditure budget Interact with internal and external customers on regular basis.
• Participates and supports regulatory/customer audits.
• Other duties as required.

 

Who You Are:

 

Minimum Qualifications:

• Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required. Master's degree in a scientific discipline or related discipline desired but not required.
• 10+ years of successful demonstration of the key responsibilities as presented above with in biologics or pharmaceuticals and previous people leadership experience.
• Demonstrated experience working in a highly matrixed, GMP manufacturing setting.
• Strong understanding of microbiology (Endotoxin and Bioburden testing); contamination control; Cleanrooms and Aseptic manufacturing; Environmental monitoring etc.
• Strong understanding of microbiological methodology and laboratory techniques, specifically USP<85>; USP<61> and USP<62>.
• Knowledge of Laboratory Information Management System (LIMS).

 

Preferred Qualifications:

• Demonstrated leadership, people development and team building skills.
• Requires prior managerial experience.
• Solid track records in method development, method verification and validation
• Strong written and verbal communication skills.
• Strong problem solving skills.
• Strong computer skills, including word processing, and Quality systems databases.
• Knowledge of GMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
• Knowledge of FDA practices and guidelines.
• Knowledge of pharma/biotech bulk and finished product manufacturing and microbiological testing requirements.
• Expertise in aseptic principles and practices
• Knowledge of ICH Q7A, 21CFR, Eudralex GMP regulations,