Evofem Biosciences, Inc., (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in
women’s sexual and reproductive health. Evofem Biosciences exists to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs). The Company is leveraging its
proprietary Multi-purpose Vaginal pH Regulator™ (MVP-R) platform to develop Phexxi™, which if approved will be the first on-demand and female controlled MVP-R birth control method in the U.S.
We are a growing team based in San Diego, CA. Our sole purpose is also our soul purpose: to improve the lives of women. We are committed to discovering and developing innovative healthcare solutions that put women first.
Director/Sr. Director of GxP Compliance
Job Summary:
Reporting to the Vice President of Quality Assurance, this position will be responsible for managing the GxP (GCP/GLP/GMP) process for the Internal/External Audit program, Documentation and Training, in support of a GxP Quality Management System.
Job Responsibilities:
The position will encompass various tasks including but not limited to the following:
• Working with the Evofem Quality Vendor Management function to perform audits of Contract Organizations (CMO/CRO/CTL) to ensure compliance with Evofem quality expectations and cGxP’s.
• Developing, implementing and improving a quality system for internal and external auditing.
• Developing, Implementing and improving a quality system for training.
• Managing a small team of Quality Associates/Contractors responsible for auditing.
• Tracking and reporting compliance metrics.
• Work closely with Evofem Management and Departmental staff in support of the Quality Management System.
• Work with various user groups to facilitate auditing and training processes.
• Providing general Compliance support for the overall Quality System in place at Evofem.
• Managing the documentation/archiving of GxP documents.
• Additional responsibilities will include assisting in other Compliance activities to include: Recall Management, Annual product reviews, Regulatory Inspection logistics, and providing general Compliance support for the overall Quality System in place at Evofem.
Competencies:
• Ability to work effectively independently and in team environments.
• Excellent interpersonal, communication, analytical, organizational and managerial skills.
• Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
• Ability to work in a fast-paced environment.
• Demonstrated ability to manage multiple completing tasks and demands.
• Ability to work independently, take initiative and complete tasks to deadlines.
Supervisory Responsibility:
• Manages a small team of Quality Associates and Contractors.
Education and Qualifications:
• Bachelor’s Degree required; Bachelor’s Degree or higher in a scientific discipline preferred.
• Minimum 10 years of experience in a regulated industry required; in a Quality auditing role preferred.
• Other requirements include: understanding of FDA/EU GMP/GCP/GLP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices; and experience training personnel on auditing systems and Quality Compliance concepts.
• Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is a plus.
• Experience in working within document control systems is preferred.
• Experience with Electronic Document and Quality Management Systems preferred.
• Experience with general Quality Management Systems in a regulated environment, personnel management of small teams, job history with a focus on auditing, and will be expected to interact with many groups across the organization, at all levels.
Travel:
• Ability to travel up to 35% – domestic and international