Quality Assurance Senior Supervisor

4w4 weeks ago

Johnson & Johnson

Athens, US · Full-time · $85,000 – $110,000

About this role

The Quality Assurance Senior Supervisor is responsible for the effective supervision and operation of the site Quality Investigation Unit, under the guidance of the Site Quality Head. This role ensures that the Quality Investigations Unit functions are aligned with cGMPs and FDA guidance.

Supervises and coordinates the unit’s resources activities, providing support, guidance, advice and continuous monitoring/feedback to the Senior Investigation Quality Leaders. Ensures that final investigation reports are thorough and completed on a timely basis, while monitoring progress and resource allocation.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. The Quality Assurance Senior Supervisor works within the Innovative Medicine division in Athens, GA.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. As guided by Our Credo, we provide an inclusive work environment where each person is considered as an individual.

Requirements

Knowledge of current Good Manufacturing Practices (cGMPs) and FDA regulatory guidance for the pharmaceutical industry.
Experience in leading and supervising teams, with the ability to provide direction to direct and dotted-line reports.
Strong understanding of event investigation processes and root cause analysis methodologies.
Proficiency in reviewing and ensuring accuracy of investigation reports and documentation.
Ability to monitor, trend, and evaluate root causes to assess effectiveness of corrective actions.
Experience in resource management and anticipating staffing needs for investigation activities.
Familiarity with Good Documentation Practices and site SOPs.

Responsibilities

Supervise the Senior Investigation Quality Leaders and coordinate overall activities related to the investigation of events at the Innovative Medicine Athens, GA site.
Ensure that all events are thoroughly investigated as per cGMPs, FDA, and other regulatory pharmaceutical industry guidance, and that final reports are accurate, adequately issued, and timely completed.
Provide leadership and direction to dotted/direct reports to satisfy both Johnson & Johnson Innovative Medicine and regulatory agency requirements for event investigations.
Review investigation reports and monitor progress to ensure timely completion consistent with cGMPs, Good Documentation Practices, site SOPs, policies, and site operations needs.
Monitor investigation unit activities to ensure adequate resource assignment and anticipate the need for additional assistance to complete reports.
Monitor, trend, and evaluate root causes identified in investigations to review effectiveness of previously implemented actions or recommend improvements to Quality Systems in light of gaps identified.

Benefits

Inclusive work environment that respects diversity and recognizes individual merit.
Opportunity to work within Innovative Medicine, developing treatments and finding cures.
Supportive culture guided by Our Credo, emphasizing responsibility to employees.