Analytical Compliance Manager

Revance • Newark, CA

7h • Hybrid

About The Position

Analytical Compliance Manager | Remote or Hybrid | Annual Bonus
Revance (a Crown Laboratory Company) is seeking an Analytical Compliance Manager to contribute to our growing Analytical Development team. The incumbent will participate in a team responsible for all aspects of method development and qualification/validation documentation of complex biologics, as well as systems onboarding. This position requires a thorough understanding of GxP processes, documentation, operation process workflow of a laboratory environment, project management concepts, and technical concepts.

This position leads analytical compliance activities across multiple programs. The ideal candidate will be expected to work collaboratively and cross-functionally with Validation, IT R&D, CSV, Quality Assurance, QC, and other technical groups to drive program progression.
Reporting to: Associate Director, Analytical Development
Location: Remote/Hybrid in Newark
Salary Range: $117k - $163k + 10% annual bonus
the final salary offered will depend upon factors that may include, but are not limited to, the quality and length of experience, education, and geographic location.

Requirements

• Master’s degree in biological sciences or related field with 2+ years of progressive experience in the biotechnology or biopharmaceutical industry. (Strong candidates with a bachelor’s degree may be considered)
• Experience in project management.
• Experience in Continuous Improvement and/or Lean Six Sigma.
• Experience developing/authoring protocols, methods, reports, SOPs, and technical documents.
• Experience in system validation, CSV, system onboarding/implementation.
• Experience performing root cause analysis, identifying CAPA, and confirming effectiveness.
• Familiarity with ICH guidelines and FDA regulations.
• GxP knowledge.

Nice To Haves

• Experience in BlueMountain.
• Experience in QUMAS.
• Experience in Veeva.
• Experience in Smartsheet, Notion, and/or Monday.
• Experience in performing change control, deviation, laboratory investigation, and/or other quality records.

Responsibilities

• Author and review analytical methods, protocols, reports, SOPs, and other technical documents, including instrument qualification, change control, investigation, and deviation.
• Maintain sophisticated analytical instrumentation and associated computer control systems (including PM and PMOQ scheduling and management).
• Onboard and implement LabVantage (for LIMS, ELN, and inventory).
• Be part of a team that establishes, maintains, and improves technical operation workflow and project outcomes in the Analytical Development area.
• Provide support for laboratory operations – inventory tracking, sample management, and documentation review.
• Ensure adherence to GMPs, GLPs, GCPs, and GDPs where required.

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO (12 days' PTO), holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager