Looking to make a difference in the world? If you’re ready to help grow our business and expand market share… then we’re looking for you!
We have an immediate opening for a Senior Manager - Global Quality Systems
The person selected for this position MUST be located in either Tucson, AZ or Los Angeles, CA, or willing to relocate.
As a member of the Quality Assurance team, this role is responsible for management, maintenance and global quality system for all company services and product lines in both domestic and international markets. Reviews metrics of all quality system elements and drives continuous improvement projects and corrective and preventive actions as needed. Assists with due diligence activities related to acquisitions and assists with integration and harmonization as needed.
Essential Duties & Responsibilities:
Leads development, implementation and oversees quality systems to support and ensure compliance with FDA regulations and international tissue & medical device regulations, and accreditation standards; includes cGMP and cGTP, state licenses and accrediting body standards (ISO, AATB, AABB)
Works with business stakeholders to identify areas for harmonization and efficiencies.
Supports merger and acquisition activities by leading diligence efforts and subsequent integration projects relating to quality systems.
Stays abreast of current US and international industry trends and new regulations in order to analyze and anticipate their impact on the organization
Manages all quality data for the global business units and provides visibility to trends and/or deficiency where applicable.
Leads and supports a corporate culture of quality and compliance by diligently mentoring and developing staff, through regularly communicating vision, priorities, and complex operational requirements to both direct reports and senior leadership
Develops an in-depth understanding of existing processes, the needs of clients, and the needs of strategic partners in order to identify opportunities for process improvement and the tools necessary to both implement and measure plans of correction through direct engagement and analysis of data
Leads projects in the quality and regulatory department to ensure timely completion.
Extracts, analyzes, and evaluates various types of data and provides data-driven recommendations to Executive Leadership.
Establishes or re-engineers processes to improve the operational efficiencies and minimizes technical difficulties. Quickly identifies solutions to problems and assures corrections are expeditiously implemented
Manages all employees in the Quality Systems department
Education and Experience:
Bachelor’s Degree and 6-8 years of related experience OR Associate's Degree and 15+ years of related experience
10 or more years working in an FDA-compliant environment required
ASQ certification and some level of Six Sigma training strongly preferred
Experience in either Biologics or Medical Devices required; both strongly preferred
Global experience required
Experience in private equity funded organization is preferred
Experience leading external regulatory inspections and re-accreditation required
Proficiency in MS Outlook, Word, Excel, and PowerPoint
Experience with MasterControl a plus
Other Skills and Abilities:
Excellent attention to detail; interpretive skills; problem-solving skills, customer service skills; project management skills; ability to maintain confidentiality; strong interpersonal skills to interact with peers and management; follow-through, and proactive nature/ability to take initiative; excellent organizational skills; and ability to manage multiple tasks simultaneously.
This role may cover multiple locations and will be required to travel to those domestic locations. Travel is anticipated to be less than 10% of the time.
Internal Number: 1142
About Generate Life Sciences
Giving people the opportunity to grow and protect their family has been at the heart of Generate Life Sciences for over 40 years.
Generate is a first-of-its-kind organization focused on helping grow and protect healthy families through reproductive, newborn stem cell, genetic screening, medical device and healthcare technology services. Generate serves families from preconception to post-birth throughout the significant and highly personalized journey of building a family and protecting their children’s health. Built upon the pillars of innovation, access, and connection, Generate has already helped grow and protect nearly 1 million families around the world.
Our legacy brands – CBR™, California Cryobank Donor Sperm Bank™ and Donor Egg Bank USA™ – are pioneering leaders in their respective fields and continue to set industry standards for innovation, scientific excellence, and customer focus. Generate is furthering the impact of this life sciences platform with the addition of advanced pediatric genetic testing, US distribution of reproductive medical devices and proprietary healthcare technology through the respective brands – ReadyGen™, Kitazato USA™ and Donor Applicati...on™.
Headquartered in Los Angeles, Generate operates facilities in Tucson, New York, Boston, Palo Alto, and Rockville, MD. Generate is a portfolio company of GI Partners, a private investment firm based in San Francisco.
Our dedicated team of over 450 doctors, scientists, and staff are constantly pursuing new research and technological advances to help connect the possibilities of life with the opportunities of science for more families than ever before.
Between life and science is opportunity.