Director of Quality and Regulatory - NY. NJ, PA (Remote)
We are a leading global provider of high-quality biological specimens and value-added services. By combining technical expertise, exceptional customer service, and unparalleled access to biological specimens. Our mission is to provide high quality biological tissues, fluids, cell products, and services to our customers to further pharmaceutical research focused on bettering lives.
Our global team is made up of a diverse group of professionals committed to serving the needs of our 30,000 clients around the globe. Our culture’s core values consist of respect, integrity, accountability, communication, and quality. We operate in a fast-paced environment that, while in operation for over 30 years, maintains an entrepreneurial spirit and a “can do” attitude.
Reporting to the Vice President of Global Quality and Regulatory, this position is responsible for administering Quality and Regulatory systems with oversight of production and laboratories activities, assuring that products are manufactured and distributed in compliance with RUO, cGMP, GCP, GLP, USP and FDA guidelines where site appropriate. The position develops the overall approach to planning, execution and integration of quality and regulatory activities and supervises staff to ensure site and product quality in compliance with regulations while meeting business needs in the most efficient manner.
- Manage all regulatory and quality activities for the site and all accompanying sourcing sites
- Liaise with the FDA, customers and state regulatory bodies in ensuring regulatory compliance in support of the manufacture and distribution of biospecimens and related products. Liaise with customers, FDA and third party audits and inspections.
- Develop, implement and maintain quality systems, policies, and procedures of the company. These procedures are related to the monitoring of in-process production processes and release testing of incoming raw materials, components, and finished products according to established specifications.
- Manage processes to detect, document and execute opportunities for quality improvement.
- Communicate quality system status at the company through management reviews, quality audits, post-market surveillance and other quality management processes.
- Provide leadership in the development of regulatory strategies for development of new products or modifications of products consistent with business objectives.
- Develop and maintain compliance with Adverse event reporting requirements and customer contact systems.
- Closely interact with all facets of the company's business. Apply judgement regarding quality issues and make recommendations based on Annual and routine product reviews.
- Develop staff competencies to achieve a best-in-class quality and regulatory compliance culture
- Ensure completion of departmental tasks and projects and actively gather staff feedback and perspective
- Manage and participate in human resources/organizational development process and recruitment of key Regulatory and Quality personnel (includes staffing, employee relations, employee and organizational development).
- Ensure budgets, schedules, staffing, performance and safety requirements are met.
- Review and approve all SOPs, standard testing methods, manufacturing documents and product/raw material specification sheets.
- Effective management of 4 direct reports and a total staff to be determined once onboarding is complete.
- Manage the Quality group’s review and approval of all product documents prior to the release of products.
- Minimum 10+ years of experience in the pharmaceutical, biobanking, biospecimen management, biorepository management or related industry.
- Minimum BS in Chemistry, Microbiology or related science field. Graduate level degree is a plus.
- Experience in managing a multi-disciplined compliance organization, including quality management experience
- Experience should include 5+ years of management experience with direct reports
- Ability to integrate regulatory and quality expertise with business objectives
- Ability to translate company's corporate goals into plans
- Ability to effectively communicate, coordinate and interact with upper management, managers and personnel within other departments
- Skilled at fully understanding scientific, medical and manufacturing disciplines
- Thorough understanding of US regulatory requirements and standards for development, validation, manufacture, marketing and distribution of products
- Proven track record of success and a broad understanding of global regulatory affairs and quality management requirements. GDPR experience is a must.
- Proven track record of successful cooperative working relationships with the FDA and/or global regulatory agencies
- Progressive view of regulatory compliance and quality management and the contribution of both in a successful business strategy
- An effective leader, strong leadership, management and mentoring skills, team-oriented
We offer a comprehensive benefit package for eligible team members including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also offer a generous retirement plan with a company match. Eligible employees also enjoy competitive time-off policies. We are a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!
We can’t wait to work with you!
We are an equal opportunity employer.
BioIVTNew York, NY
ManufacturingView All BioIVT Jobs
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