About the job
We are seeking a highly motivated Quality leader who is interested in joining our fast-paced, dynamic startup environment. The CQI Manager will be responsible for oversight and implementation of all Continuous Quality Improvement initiatives at the site. This individual will work with Quality leadership to develop the strategic improvement strategy for the site which includes an appropriate resource plan and milestone-based accountability process. The CQI Manager works closely with Project Review Board to ensure interdepartmental objectives are defined and quality assurance is incorporated; core to these activities will be the ability to effectively manage projects and foster effective cross-functional partnerships. The CQI Manager will also work with business units to perform weekly walkthroughs and internal audits. Individual 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. The individual holding the position of CQI Manager shall be responsible for scheduling customer audits, leading regulatory and customer audits, tracking corrective and preventative actions identified within audits and submitting responses in a timely manner. This person will also be responsible for continuous site quality training and yearly cGMP training.
Responsibilities:
- Supervises all Continuous Quality Improvement staff providing learning and development where appropriate
- Ability to evaluate current state practices and analyze gathered data to identify opportunities for continuous improvement.
- Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
- Conduct or direct the internal investigation of compliance issues.
- Responsible to work with sales team in scheduling on-site customer audits.
- Responsible for leading all customer and regulatory audits.
- Track corrective and preventative actions identified within audits, work with various units for completion and submit responses to agencies/customers when required.
- Conduct off-site audits of third parties and vendors with detailed report of findings.
- Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
- Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities.
- Assists in developing policies and procedures related to QA
- Manage direct reports – Lead and coach team driving a high performance organizational culture.
- Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
Set yourself apart
You possess the following qualifications, background and abilities:
- Bachelor’s Degree in Life Science or related field.
- Minimum 5 years prior experience in Quality Assurance / cGMP / FDA regulated industry
- Ability to effectively communicate and lead
- Decision making ability
- Oversight of operations with a focus on Sterility Assurance
- Ability to multi-task and prioritize
- 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.
- Audit experience is required.
Candidate Profile:
- Experience with inspections and inspection readiness activities required. Experience leading audits preferred.
- Experience communicating and/or responding to regulatory agencies preferred.
- 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.
- Excellent communication skills:
- Listening, interpreting and summarizing information
- Clear and concise verbal communication
- Professional and concise written communications –exceptional attention to detail
- Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
- Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
- Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
- Strong project management skills: MS Word, Excel, PowerPoint,
- Flexible and able to adapt to company growth and evolving responsibilities.
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.