QA Manager, Aseptic Manufacturing Oversight

Nature and Scope

The QA Manager, Aseptic Manufacturing Oversight ensures that American Regent operates in compliance with all applicable procedures and regulations. The role is responsible for providing oversight for Aseptic Processing Area (APA) in relation to aseptic practices and behaviors, including direct managerial responsibility for the Sterility Assurance function and video monitoring staff. The role has full signatory authority and accountability for quality/compliance matters within the scope of responsibility.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Oversee qualification and periodic requalification of new employees and current APA personnel to ensure continued aseptic processing competency and compliance with applicable procedures and regulatory expectations.

• Provide oversight of video monitoring programs for aseptic operations, including review, escalation, and follow-up of observations to support contamination control and operator behavior expectations.

• Provide quality oversight of media fill planning, execution, documentation, exception management, and post-execution assessment to verify aseptic process control.

• Oversee Environmental Monitoring and Personnel Monitoring events, including review of results, assessment of adverse trends, escalation of excursions, guiding risk assessment and confirmation of appropriate investigation and corrective action.

• Lead and support lifecycle risk assessments for aseptic processing activities, contamination control strategies, facility/equipment changes, and process improvements, ensuring risks are identified, evaluated, mitigated, and periodically reassessed.

• Provide quality oversight of airflow visualization studies, including protocol review, execution support, observation assessment, documentation review, and evaluation of findings for impact to aseptic operations.

• Direct responsibility and oversight of the Sterility Assurance staff and video monitoring staff.

• Review and approval of cGMP documentation including protocols, procedures, policies, and change controls.

• Review and approval of deviation investigations and CAPAs.

• Oversee manufacturing activities to ensure adherence to procedures. This includes direct observation, video review and frequent contact and alignment with operations, engineering and maintenance stakeholders.

• Develop and improve quality systems to ensure quality compliance and adherence to cGMPs.

• Develop and manage quality metrics related to aseptic behaviors / practices and state of microbial control for the APA, identify trends, and take action as appropriate.

• Lead risk management activities and develop mitigation plans as appropriate.

• Actively Participate in cross-functional project teams.

• Collaborate with colleagues to achieve desired outcomes.

• Make recommendations for improvement and procedure and processes.

• Support, coordinate, and interface with regulatory agencies as required in support of regulatory agency inspections.

• Support and maintain Quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.

• Provide expectations, goals, coaching, and annual performance reviews for subordinates.

• Keep informed about current good industry practices and suggest areas of improvement.

• Consistently perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.

• Perform any other tasks/duties as assigned by management.

Education Requirements and 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.

• Bachelor’s degree, required.

• 5+ years of relevant experience providing oversight in a GMP setting with 1-3 years of people management experience, required.

• Minimum of 5 years of sterility assurance or microbiology experience within the pharmaceutical industry aseptic manufacturing, required.

• Demonstrate critical thinking, initiative to identify opportunities and drive to implement projects independently.

• Demonstrate ability to become and remain gown qualified for APA presence.

• Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.

• Isolator technology experience, preferred.

• Demonstrate ability to perform detail-oriented work with a high degree of accuracy.

• Excellent verbal, written, and interpersonal communication skills.

• Effective time management and collaboration skills.

• Strong organizational skills, planning skills and must work effectively within teams.

• Demonstrates good stress management skills and analytical problem-solving skills.

• Ability to resolve conflicts and disagreements on regulatory compliance issues.

• Ability to occasionally travel both domestically and internationally – 10% at maximum.

Physical Environment and Requirements

• May have to wear protective clothing in the laboratories and manufacturing areas for access as required for safety and product controls.

Expected Salary Range:

$117,900 - $137,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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