Analytical Compliance Manager

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.

Responsibilities/Essential Duties:

• 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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Company Summary:

Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• 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!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.