Hybrid Senior Change Control & Qualification Manager

Altria Client Services LLC; Richmond (VA); Hybrid; USD 120,000 - 173,000; Full time

Benefits offered by this job

Hybrid work arrangement

Paid time off and holidays

401(k) matching

Professional development stipends

Parental and bonding leave

Medical, dental, and vision coverage

Job summary

Altria Client Services LLC in Richmond, VA (hybrid with locations in Nashville, TN or Hopkinsville, KY) seeks a Manager, Change Control and Qualification to lead the Quality organization. You will drive cross-site governance and risk-based decision making, and mentor a team to ensure compliant change control and qualification processes.

Responsibilities include establishing review cadences, improving documentation, reducing defects, and reporting key metrics to leadership, while ensuring

Qualifications

• Bachelor's degree or Advanced Degree preferred.
• 8+ years of experience in a regulated environment with change control understanding documents.
• Understanding of FDA and other regulatory processes.
• Advanced written and editorial skills, and strong attention to detail. Demonstrated ability to synthesize complex information using excellent critical thinking skills while using risk based decision making.
• Strong communication and organizational skills and proven ability to meet timelines.

Responsibilities

• Drives portfolio-level decisioning rigor by establishing review cadences, arbitrating cross-functional conflicts, and approving dispositions for high-risk changes.
• Drives documentation control performance through governance and metrics, analyzing recurring defects in change and qualification records and implementing corrective standards that prevent them from repeating.
• Drives governance effectiveness by improving forums, resolving systemic bottlenecks, and standardizing change control and qualification execution across teams and sites.
• Reports cycle time, backlog, and quality performance to Quality leadership.
• Aligns platform stakeholders across functions to improve decision quality, reduce recurring impact gaps, identify and inform regulatory compliance questions and reporting, and prioritizes system enhancement requests with system owners.
• Manages a team of change control and qualification professionals. Sets performance expectations and objectives, allocates work across the portfolio, develops technical depth in both disciplines, and conducts performance and development conversations.

Skills

Change control

Regulatory processes

Leadership

Risk-based decision making

Communication

Editorial skills

Education

Bachelor's degree or Advanced degree

Job description

Altria Client Services LLC in Richmond, VA (hybrid with locations in Nashville, TN or Hopkinsville, KY) seeks a Manager, Change Control and Qualification to lead the Quality organization. You will drive cross-site governance and risk-based decision making, and mentor a team to ensure compliant change control and qualification processes.

Responsibilities include establishing review cadences, improving documentation, reducing defects, and reporting key metrics to leadership, while ensuring