About the job
We are seeking a highly motivated Quality leader who is interested in joining our fast-paced, dynamic startup environment. This position will report to the Director of Quality Assurance. The Environmental Monitoring Manager will manage staff through site supervisors or directly to maintain sample schedules, and work with site leadership in continuous improvement initiatives. The EM Manager must have a high level of knowledge of microbiological techniques, designing and maintaining an environmental monitoring program to GMP compliance and laboratory documentation as required per 21 CFR Part 11 procedures. The EM Manager is expected to build effective partnerships with department heads to help drive the business toward achieving company objectives. Incumbent will apply quality management and continuous improvement theory, technical principles, and expert judgment to proactively assist the business in the identification of potential risk and lead activities to ensure mitigation and improve 503B compliance and enhance performance of key 503B activities. Core to these activities will be the ability to effectively manage projects and foster effective interdepartmental and cross-functional partnerships.
- Oversee/execution of the environmental monitoring program and batch level environmental monitoring program.
- Ensure the Quality Control Microbiology and Environmental Monitoring laboratories have appropriate resources, both staffing and equipment.
- Develop team key performance indicators (KPI) and analyze for opportunities to optimize department performance.
- Work effectively within the site leadership team to ensure the testing is performed on time and in compliance with company SOPs.
- Participate/lead root causes analysis exercises.
- Author/Review SOPs as necessary.
- Responsible for representing and leading the company during audits, visits, and technical calls.
- Responsible for representing all environmental monitoring aspects at the site level.
- Manage direct reports – Lead and coach team driving a high performance organizational culture.
- Gather, organize & analyze data to develop solutions & alternative methods of proceeding; execute continuous improvement projects to optimize operations to deliver process improvements
- Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
- Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
- Conduct or direct the internal investigation of compliance issues.
- Assess product, compliance, or operational risks and develop risk management strategies.
- Conduct environmental audits to ensure adherence to environmental standards.
- Identify compliance issues that require follow-up or investigation.
- Disseminate written policies and procedures related to compliance activities.
- File appropriate compliance reports with regulatory agencies.
- Evaluate testing procedures to meet the specifications of environmental monitoring programs.
- Verify that software technology is in place to adequately provide oversight and monitoring in all required areas.
- Discuss emerging compliance issues with management or employees.
- Advise internal management or business partners on the implementation or operation of compliance programs.
- Provide assistance to internal or external auditors in compliance reviews.
- Develop or implement environmental compliance plans for programs, such as air, surface and personnel sampling.
Set yourself apart
You possess the following qualifications, background and abilities:
- BS/BA degree with 5 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
- Minimum 2 years directly related experience supporting compliance in a quality/compliance function /applicable compliance field.
- Knowledge of QMS and CAPA related tools or systems is required.
- Environmental monitoring and audit experience is required.
- B.S. or higher degree in Microbiology/Biology/Biochemistry or related science with a minimum of 7 years of GMP pharmaceutical microbiological laboratory experience and 5 significant years of leadership of multiple staff members and teams.
- Must have environmental monitoring regulatory knowledge
- Experience in a FDA regulated industry.
- Experience with compendia microbiological methods, alternative microbiological methods, and aseptic techniques used in sterile fill operations.
- Demonstrated skills in conducting OOS investigations, root cause analysis, and implementation of corrective actions.
- Experience with participating in FDA and other regulatory authority audits.
- Strong personal leadership with demonstrated competency interfacing with senior leaders is required
- Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.
- Proficient in listening, interpreting and summarizing information
- Must have excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts.
- Must be able to work in the absence of complete information and remain able to make timely, high quality decisions.
- Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
- Must have a strong ability to work in a team environment while possessing the ability to remain focused when working alone on a project.
- Demonstrated experience in product/solution planning.
- Strong presentation skills.
Ability to actively engage customers to devise products, provide solution planning and issue resolution as the subject matter expert.
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.