Manager, Quality Assurance

Job Summary:

The Manager, Quality Assurance is responsible for QA oversight of internal and external operations in support of Revance commercial and clinical products. Furthermore, the role will provide quality assurance management support to the cross-functional CMC teams and ensure compliance with cGMP requirements (US and EU), in-house SOPs and standards both in-house and to Revance’s third party contractors as it relates to manufacturing and testing of the raw materials and products.  The individual will manage, develop and train QA personnel and write performance reviews.

Reporting to:     VP, Quality Assurance & Validation

Location/Territory:     Newark, CA (100% onsite)

Salary Range:     $117,875 - $162,046

Responsibilities/Essential Duties:

• Provide quality assurance oversight for production, testing and release of clinical and commercial products/materials manufactured in-house or by CDMOs.
• Supporting QA activities related to projects for onboarding/qualifying CXOs from tech transfer through health authority approval.
• Provide quality assurance oversight for production, testing and release of packaging activities at 3PL vendor(s).
• Provide for lot dispositions of Revance commercial and clinical products/materials manufactured in-house or by CDMOs.
• Lead or support activities for, and maintain QA processes related to, product complaints, recalls, and biological product deviations.
• Provide quality assurance oversight for in-house operations (production, facilities, laboratories, and materials management)
• Release of raw materials (e.g., chemicals, packaging and labeling components, etc.), including incoming quality attribute inspections and retain sampling.
• Support for establishing and maintaining quality agreements for key suppliers.
• Implement and maintain programs and processes to ensure high quality products and compliance with cGMPs and GLPs.
• Organize and prioritize group tasks, and provide job skills training and mentoring of personnel.
• Review and approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, sampling plans, test methods, specifications, and protocols and reports for method validations and stability studies.
• Act as a compliance resource to provide guidance and assistance around aseptic processing and towards resolution of complex deviations, quality investigations, lab investigations, CAPAs and change controls; review and approve quality system documents related to manufactured products.
• Ensure consistent quality standards across multiple CDMOs, CTLs, and 3PLs.
• Support QA reserve sample management.
• Support for Annual Product Review Program.
• Support Quality Review Board meetings.
• Maintain product quality assurance performance metrics.
• Support regulatory agency inspections or third party audits by participating in inspection preparation and assisting the inspection strategy room.

Basic Qualifications:

• Master’s degree & 2 years’ directly related experience; OR
• Bachelor’s degree & 4 years’ directly related experience; OR
• Associates degree & 8 years’ directly related experience; AND
• 1 years’ managerial experience directly managing people, projects, programs or resources

Preferred Qualifications:

• BS degree in Chemistry, Biology or equivalent.
• Master of Science in related field.
• Minimum 4 years’ experience in the pharmaceutical or biotechnology industry with at least 2 of those years in QA or a closely related field.
• Comprehensive expertise and working knowledge of 21 CFR Parts 201, 211, 820, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
• Experience working with CDMOs.

• Experience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences.
• Strong interpersonal, analytical, organizational and leadership skills.
• Excellent written and verbal communication.
• Ability to handle multiple time constrained projects simultaneously.
• Excellent interpersonal, verbal and written communication skills.
• Experience in aseptic processes, and knowledge of biologics.
• Ability to manage multiple projects; experience with process validations is desired.
• Good working knowledge and understanding of US and international (e.g. EU, ICH) cGMP regulations, procedures and guidelines that govern manufacturing, and quality control and quality assurance of biologics/drugs produced for clinical trial investigations and marketed products.
• Attention to detail with an ability to perform critical review of various types of technical documents.
• Proficient with commonly used word processing, database systems and other software.
• Prior experience with regulatory inspections.

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 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.