About the job
We are seeking a highly motivated Quality leader who is interested in joining our fast-paced, dynamic startup environment. The MQA Manager is responsible for providing Quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance. The MQA Manager works closely with Operations personnel and Environmental Monitoring Technicians to complete on-the-floor audits and training of behavior and technique. The MQA Tech will also work with Operations personnel to perform in-process batch record review and assure good documentation practices are being followed. The MQA Manager will be expected to recommend corrective actions and process improvements to reduce the potential for deviations. The individual holding the position of MQA Manager shall be responsible for the timely review and correction of documentation associated with the operations batch record. This person will also be responsible for assisting in actions associated with environmental issues, placing batches on hold and communicating with Operations and Quality Assurance the status of production batches. 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.
Responsibilities:
- Supervises all Manufacturing QA staff providing learning and development where appropriate
- Ability to make QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
- Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.
- Provides review/approval of production specific Deviations / Investigations, CAPAs, Change Controls
- Generates procedures related to Manufacturing QA functions / activities
- Periodically review records to verify that quality standards for each drug product is met
- 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
- Responsible for maintaining QA records associated with internal and external testing
- Responsible to maintain all testing equipment in compliance, calibration and certification.
- Assists in developing policies and procedures related to QA
- Promptly communicates with Operations regarding complaints, product issues/variances.
- Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
- Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles.
- Support all regulatory and customer quality audits.
- 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.
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.
- Environmental, monitoring or audit experience is an asset
Candidate Profile: - Experience with inspections and inspection readiness activities 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.
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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.