Job Summary:

The Sr. Manager, Facilities Compliance will be responsible for site compliance for the Facilities Department. Responsibilities include ensuring completeness of documentation and support to the identification and management of deviations, CAPA, and other quality events associated with Facilities, as required.

Reporting to: Executive Director, MSAT & External Manufacturing

Location: Newark, CA

Salary Range: $135,500 – $186,300

Responsibilities/Essential Duties:

Manage Facilities Compliance and Training. This includes mentoring and developing exceptional individual contributors and operation leads.
Lead the development vision and decision-making alignment across groups.
Work through a team to deliver quality commitments on time.
Create and enhance a culture of teamwork, collaboration, and communication across the Facilities organization.
Build effective cross-functional relationships across the Newark facility.
Establish department goals, tracking, and reporting KPIs, and driving continuous improvement efforts.
Lead Operational Excellence initiatives by actively collaborating with Facilities leadership.
Identify and mitigate risks in Facilities operations.
Ensure and support the Facilities inspection readiness efforts.
Review and approve documents, including standard operating procedures and all applicable equipment documentation.
Ensure deviations, CAPA, change control records, and other quality deliverables are well supported.
Ensure that projects, change controls, and other business drivers are collectively supported within supervisory groups.
Work well with a team, and collaboratively across areas outside lines of responsibility.
Ensure compliance with applicable regulatory guidelines and regulations.
Administrator of the Computerized Maintenance Management System.
Provide compliance input on capital projects to upgrade or expand facilities and equipment needed.
Establish and maintain working relationships with key facility stakeholders - Quality, Manufacturing, and Technical groups - to ensure efficient management of Revance facilities operations.
Ensure compliance of the site, and especially of Facilities & Engineering operations relative to applicable US and international regulatory agencies including OSHA, EMEA, and FDA.
Support Facility shutdowns to ensure PM’s and repairs are completed in a timely manner.
Collaborate with Quality Assurance to ensure cGMP compliance.
Support review of executed batch records or equivalent documents from CMOs.
Perform other duties or leads other small facilities related projects.

Basic Qualifications:

Master’s degree & 4 years’ directly related experience; OR
Bachelor’s degree & 6 years’ directly related experience; OR
Associate’s degree & 10 years’ directly related experience; AND
3 years’ managerial experience directly managing people, projects, programs or resources

Preferred Qualifications:

Minimum of 9 years’ experience in Facilities, including cGMP API and DP manufacturing.
Minimum of 5 years’ leadership/supervisory experience.
Working knowledge of biological processes, equipment, and facilities.
Experience with potent compounds or CDC Select Agent and Toxin regulations.
Exceptional written and oral communication skills.
Familiar with the Microsoft Office suite of products.
Attention to detail.
A customer service focus.
Excellent teamwork and leadership skills.
Advanced knowledge of understanding of Document Control standards, practices, and principles.
Advanced knowledge of understanding of Quality Systems and applicable GMP regulations and standards.
Demonstrate ability to perform detail-oriented work with a high degree of accuracy.
Effective written and oral communication skills.
Effective time management and interpersonal skills.
Possess initiative and be proactive.
Experience with databases, and advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.
Excellent organizational and planning skills.
Work effectively within teams.
Build productive internal and external working relationships.
Demonstrate good coping skills and analytical problem-solving skills.

Company Summary:

As a commercial-stage biotechnology company focused on innovative aesthetic and therapeutic offerings, Revance is setting the new standard for its clients through disruptive products, and for its employees through industry-leading benefits, which promote financial and physical well-being for all. It’s time to rethink everything you thought an employee experience could be.

What Revance invests in you:

Competitive Compensation including base salary and annual target bonus
Flexible unlimited PTO, summer & winter shutdowns, and 12 weeks parental leave
Generous healthcare benefits (Company pays up to 90% of premiums for medical benefits), Employer HSA contribution, 401k match, tuition reimbursement, wellness discounts and much more

Note: Revance has agreed to merge with Crown Laboratories. Upon completion of this merger, benefits are subject to change.

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.”

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual’s race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

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