SUMMARY

As the leader of the site Quality Management team, the QA manager will coordinate with test facility management (TFM) to carry out activities to promote, support and encourage a culture of quality across the site. The leader will work with corporate quality to ensure areas of overlap within the company are harmonized to corporate standards. As applicable, the QA manager will ensure relevant aspects of the company’s business comply with company quality policies, procedures and applicable FDA Good Laboratory Practice (GLP) regulations. The QA manager will spend a significant amount of time developing training material and training relevant staff to efficiently comply with such regulations and policies in a fit-for-purpose manner that effectively achieves the company’s business needs.

This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), FDA Guidelines, general State and Country Regulations such as but not limited to (CLIA, CAP, USP, ISO 9001, USDA regulations, DEA and State Controlled Substance programs) where site appropriate.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Provides leadership in the development and implementation of an effective FDA GLP training program for relevant staff. Stay abreast of applicable new and revised regulations. Communicate relevant information to staff and TFM.
• Regularly report to TFM regarding compliance with FDA GLP regulations as applicable to achieve the company’s business needs.
• Conducts various activities to adequately report on FDA GLP compliance, including facility inspections, inspections of computerized system installation/validation, audits of study protocols, data, in-process laboratory activities, reports, SOPs, and other activities as applicable.
• Ensure timely reporting of any deviations that may affect integrity of applicable studies.
• Compile audit findings into written reports describing the findings; submit to appropriate personnel, review responses and conduct follow-up as necessary.
• Review executed Computer System Validation protocols.
• Maintain organized and accurate QA records, prepare and submit QA records for archival as required.
• Develop and oversee QAU auditing procedures and QA SOPs and direct departmental work/scheduling.
• Host and manage client inspections and act as liaison for regulatory agency inspections.
• Communicate with clients and suppliers regarding quality or regulatory aspects and requests as needed.
• Perform corporate internal and external audits as needed.
• Supervises employees in accordance with the organization’s policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; supporting managers/directors in performance appraisals; reviewing weekly timesheets and time-off requests; providing regular feedback, and setting individual goals aligned with team and department goals.

TELECOMMUTING REQUIREMENTS (Hybrid Position):

While telecommuting, the employee is required to have a designated, in-home workspace and reliable internet connection.

The employee is expected to be onsite a minimum of 3 days a week.

TRAVEL

This position may require up to 30% travel over the course of a year.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

• Bachelor’s degree (B.S./B.A.) from four-year college or university; or high school graduate with 6-7 years of related experience and/or training; or equivalent combination of education and experience. Bachelor’s degree in a biological or chemical science field preferred.
• Minimum of 3 years of supervisory experience

Certificates, Licenses, Registrations Required

• RQAP-GLP and/or ASQ certification or ability to sit for such certification exam is preferred.

Other Skills and Abilities

• Proficiency in a variety of computer software programs including MS Office
• Ability to work in a team laboratory environment with knowledge or familiarity with scientific terminology.
• Proficiency in MasterControl is preferred but not required.

PHYSICAL DEMANDS

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

While performing the duties of this job, the employee may be required to: stand; walk, sit, stoop, kneel, crouch, crawl, speak, hear/listen, smell, display manual dexterity, reach with hand and arms. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 30 pounds.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

While performing the duties of this job, the employee will be working in professional office environment using standard office equipment. While performing the duties of this job, frequently required to use personal protective equipment to prevent exposure to hazardous materials. The employee has potential for exposure to fumes, airborne particles and toxic or caustic chemicals, biohazards, flammable liquids, risk of radiation. The employee is occasionally required to use equipment with moving mechanical parts, with risk of electrical shock and vibration. The noise level in the work environment is usually moderate, at times, the noise level can be louder and hearing protection may be required. The employee may work both inside and outside in heat/cold, wet/humid, and dry/arid conditions.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.