QC Microbiology Manager

The Manager, QC Microbiology plans, organizes, schedules, and directs the department to effectively utilize employees and equipment to meet and exceed cGMP requirements, established KPIs, and material utilization while adhering to quality control-microbiological and technical standards. The Manager provides direct on-site analysis of the day to day operation including adjustment of workflow, test performance, and quality compliance.

Essential Functions And Responsibilities

Devising sound hiring strategies based on business needs (S&OP and LE). Maintaining adequate staffing by interviewing, hiring, training, and performing the competency assessment of personnel.

Performing scheduling, planning, staffing, and monitoring of workflows based on business needs.

Providing staff development through feedback aimed towards performance development and review.

Performing corrective counseling, when necessary.

Procuring appropriate supplies and equipment to maximize department efficiency while adhering to established budgetary and quality goals.

Lead equipment life cycle management & asset/investment optimization process. Evaluate and purchase equipment based on S&OP demand within the aliquoted budget.

Assure the qualification of the laboratory equipment and validation of microbial methods, approving the protocols and/or respective reports.

Overseeing or initiating in-sourcing of microbial methods to attract clients as well as generate revenue.

Work with the BD group for initiation of W.O. for any out-of-scope work done for the clients.

Providing technical oversight of area(s) of responsibility; Serving as a technical resource for problem solving and process improvement to ensure accurate test performance.

Form project teams and champion the execution of agreed projects using project management, problem-solving and operational excellence tools

Investigating and documenting non-conforming events and environmental excursions. Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records.

Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal, client, and regulatory agency audit findings.

Troubleshooting and recommending process improvements to achieve greater efficiency and meet quality goals.

Lead strategy to simplify & standardize equipment software architecture, enabling digital integration.

Assuring alignment and efficient continuity in laboratory practices between sites.

Identify and execute Continuous Improvement Projects for the department. Lead and develop best practices in the laboratory.

Leading/participating in department and cross functional meetings.

Supporting, implementing, and ensuring compliance amongst all departments, company policies, and procedures.

Ensuring compliance with regulatory agency requirements by enforcing a quality culture throughout the department.

Interacting with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.

Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols to accurately reflect current practices.

Performing microbiological and environmental monitoring data review and trending of data within established timelines.

Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing.

Delegating tasks in the department to ensure proper coverage of all required tasks in his/her absence.

Participating in and tracking group budget setting and cost containment drives.

Ensuring completion of all client QC Microbiology/Analytical requirements related to GMP cellular products and/or materials.

Interface with Regulatory Agency Inspectors/Auditors and participate in external and internal audits.

Participate in BLA filings by providing review and compilation of Analytical data required for filings.

Qualifications

BA/BS in Microbiology or relevant field required

Biotechnology Certificate and/or cGMP experience

Minimum 7-10 years of experience with environmental monitoring or within the biopharmaceutical industry

Proficient with computer software such as

Microsoft Office

MODA

Visio

Clear understanding of compliance regulations 21CFR 210/211, 21CFR 610, 21CFR 1271, 21CFR11, EU Annex 1, cGMPs, FDA Guidance on Sterile Drugs Produced by Aseptic Processing

Strong knowledge of microbiological test methods, philosophies, method validation and method transfer.

Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.

Competencies/Candidate Profile

Strong knowledge of QC Microbial/Analytical testing methodologies, philosophies, method validation and method transfers.

Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.

Excellent organizational and leadership skills

Strong written and oral communication skills

Strong business acumen

Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner

Candidate must be able to multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.

Quality Requirements

Build Quality into all aspects of your work by maintaining compliance to all quality requirements.

Ensure compliance to all FDA and global Quality & Compliance regulations (As applicable to the job function).

Attend all required Quality & Compliance training at the specified interval.

Supervisory Responsibility

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. May directly supervise the following roles based on site organizational structure:
• QC Microbiology/Analytical Associate
• QC Microbiology/Analytica Engineers
• QC Microbiology/Analytical Trainers
• QC Scientists
  
  

Minimum Required Training

Manager Training

Quality Systems Training (Deviation/CAPA/Change Control).

Training in Microbial methods and Environmental monitoring in an aseptic manufacturing environment.

Working Environment

Must have the ability to work in a team-oriented environment and with clients

Must be able to work during the weekend, holidays and as required by the company

May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.

Understanding of quality system applications

Must be able to handle the standard/moderate noise of the manufacturing facility