Manager Quality - Microbiology

The Manager Quality (Microbiology) will oversee the microbiology department including staff, process workflows, quality, safety, and client communication to ensure the reliability, timeliness, and accuracy of all results. The Manager of Quality (Microbiology) will lead and guide all aspects of our Microbiology laboratory staff, resources, equipment, and the lab environment. This position ensures safety is closely adhered to and motivates staff to focus on preventing problems before they happen. The Manager Quality (Microbiology) strengthens the overall proficiency and depth of talent in the Microbiology laboratory by establishing outstanding performance expectations and ensuring both technical and leadership skills are developed by mentoring staff.

Responsibilities

· Overall responsibility for ensuring that the QC Microbiology Lab and the Validation team have sufficient processes in place to meet all necessary regulatory and customer requirements, as well as meet all customer service needs.

· Ensure all microbiological standards are met while providing leadership/direction to the team when needed.

· Proactively manage team to meet microbiology and validation goals while also meeting/exceeding customer expectations.

· Assign microbiological testing specifications for all raw materials and finished goods in accordance with regulatory and customer requirements.

· Oversee microbiology method validations for all formulas. Assist laboratory with program organization and prioritization, with focus on USP.

· Oversee microbiological out-of-specification investigations of any non-conforming raw materials or finished goods.

· Monitor change controls for effects on the status of any micro-sensitive product or process.

· Assist in trouble-shooting any plant quality issues (all plants) specifically those related to possible microbiological contamination.

· Communicate with all levels of management to ensure quality issues are understood and preventive actions are taken.

· Champion a positive quality culture to help ensure products in the market are pure, safe & effective along with meeting customer specifications.

· Create and maintain the yearly budget for the Microbiology Lab.

· Assist contract packagers with quality issues in order to foster a positive working relationship while ensuring production and distribution of high quality products to our customers.

· Monitor all applicable regulatory publications for changes affecting microbiological testing.

· Update, maintain and strengthen all aspects of training for Microbiologists, Laboratory Technicians, Validation Engineers and designated quality personnel. Ensure all personnel keep current on data entry and generate consistent, accurate daily/monthly reports.

· Monitor and trend plant environmental data. Submit periodic trend reports to the VP of Technical Services

· Ensure quality team maintains compliance and adheres to commitment to safety in the workplace.

· Effectively address customer requests and concerns to maintain/improve customer satisfaction.

· Responsible for effective hiring, training, and development of team members. Champion attendance policy and ensure performance evaluations keep people informed, maintain open communication and provide timely, honest performance feedback with direction.

Qualifications

Education Requirements:

Bachelor’s degree in Microbiology or related field.

Experience Requirements:

A minimum of 12 years in a leadership role in an OTC (over-the-counter) drug or medical device manufacturing facility, with a majority of that experience in a Microbiology Lab environment. Extensive experience in representing multiple FDA regulated drug manufacturing and

distribution sites during FDA audits. Experience in representing an OTC company during customer audits including contract customers and 3rd party auditors. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs. Superior communication and leadership skills required.

Competencies:

Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, and knowledge of current Good Manufacturing Practices are mandatory.