Revance
Director, Quality Assurance
Revance, Newark, California, United States, 94560
Job Summary:The Director, 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 ensuring 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:
Executive Director, Quality Assurance & ValidationLocation/Territory:
Newark, CASalary Range:
$187,000 to $244,000Responsibilities/Essential Duties:Provide quality assurance oversight for production, testing and release of clinical and commercial products manufactured in-house or by CDMOs.Provide quality assurance oversight for production, testing and release of packaging activities at 3PL vendor(s).Responsible for lot dispositions of Revance commercial and clinical products.Responsible for release of raw materials (e.g., chemicals, packaging and labeling components, etc.), including incoming quality attribute inspections and retain sampling.Responsible for establishing and maintaining quality agreements for key Suppliers.Responsible for monitoring of quality performance and issue resolution for Suppliers (including monitoring of quality agreement parameters).Provide QA oversight for Process, Cleaning, and Shipping Validation.Implement and maintain programs and processes to ensure high quality products and compliance with cGMPs and GLPs.Organize and prioritize group tasks, 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 control; review and approve quality system documents related to manufactured products.Ensure consistent quality standards across multiple CDMOs, CTLs, and 3PLs.Responsible for QA reserve sample management.Responsible for Annual Product Review Program.Responsible for Recall and Biologics Product Deviation Programs.Conduct 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:Doctorate degree & 5 years of Quality Assurance experience.OR Master's degree & 7 years of Quality Assurance experience.OR Bachelor's degree & 9 years of Quality Assurance experience.AND 4 years of managerial experience directly managing people, projects, programs or resources.Preferred Qualifications:10 plus years of experience in the pharmaceutical or biotechnology industry.5 plus years of those years in QA.5 plus years in management and/or supervisory role.Comprehensive expertise and working knowledge of 21 CFR Parts 201, 211, 820, Eudralex Volume 4 and related Annexes, and ICH guidance documents.Experience of 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.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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Executive Director, Quality Assurance & ValidationLocation/Territory:
Newark, CASalary Range:
$187,000 to $244,000Responsibilities/Essential Duties:Provide quality assurance oversight for production, testing and release of clinical and commercial products manufactured in-house or by CDMOs.Provide quality assurance oversight for production, testing and release of packaging activities at 3PL vendor(s).Responsible for lot dispositions of Revance commercial and clinical products.Responsible for release of raw materials (e.g., chemicals, packaging and labeling components, etc.), including incoming quality attribute inspections and retain sampling.Responsible for establishing and maintaining quality agreements for key Suppliers.Responsible for monitoring of quality performance and issue resolution for Suppliers (including monitoring of quality agreement parameters).Provide QA oversight for Process, Cleaning, and Shipping Validation.Implement and maintain programs and processes to ensure high quality products and compliance with cGMPs and GLPs.Organize and prioritize group tasks, 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 control; review and approve quality system documents related to manufactured products.Ensure consistent quality standards across multiple CDMOs, CTLs, and 3PLs.Responsible for QA reserve sample management.Responsible for Annual Product Review Program.Responsible for Recall and Biologics Product Deviation Programs.Conduct 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:Doctorate degree & 5 years of Quality Assurance experience.OR Master's degree & 7 years of Quality Assurance experience.OR Bachelor's degree & 9 years of Quality Assurance experience.AND 4 years of managerial experience directly managing people, projects, programs or resources.Preferred Qualifications:10 plus years of experience in the pharmaceutical or biotechnology industry.5 plus years of those years in QA.5 plus years in management and/or supervisory role.Comprehensive expertise and working knowledge of 21 CFR Parts 201, 211, 820, Eudralex Volume 4 and related Annexes, and ICH guidance documents.Experience of 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.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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