Manager QC Lab Support and Compliance

Exciting new opportunity for an experienced Manager/Team Leader to join our QC Lab support and Compliance team!

Job Description

In this role, you will oversee the responsibilities of the QC Lab Support and Compliance group which includes; developing team members and career path, implement best industry practices, lead and participates in projects, participate in cross-site teams. You will be responsible for completion of personal and team goals / objectives / performance evaluations and you will complete one-to-one assessment with employees and perform performance reviews and will ensure that employees are trained.

You will support innovation, improvements and alignment of the team, and communicate the group’s activities across functional area.

Primary Responsibilities

  • Oversees management related work schedules and ensures completion of deliverables/activities
  • Timely communication to teams for unplanned scheduling changes/issues to other QC staff/management as impacts their teams
  • Escalates appropriately when time lines cannot be met with mitigation plans
  • Ensures team is focused on business and prioritization
  • Situational leadership-ability to flex and respond to unexpected situations/demands; effectively problem solve and reallocate resources as necessary
  • Provide leadership for QC initiatives as related to strategy of the business for example; cross site improvements, lead/participate to drive development of self and teams – overall strategy. Ensures global alignment.
  • Contributes to more complex projects/initiatives either through execution or ensures completion of activities including; reports, project representation (complex or those with significant impact) or management (routine or minimal complexity) through delegation
  • Ensures establishment of goals and development plans for employees
  • Maintain quality metrics for QC Department to ensure optimization and awareness
  • Provide Quality Unit oversight where designated
    Scope includes Laboratory exceptions, deviations, CAPA’s, Alert/Actions, analytical instrument validation, and general compliance oversight

 

Qualifications

  • Proven understanding and appropriate assessment of compliance, risk management, validation
  • Understanding of EU & FDA guidance, knowledge in Stability, BPDR, OOS result handling
  • 4+ years’ experience working with GMP experience and compliance oversight

Education

  • Bachelor’s degree (B.S.) in Life science or Masters degree (M.S.)


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