Associate Director, Biomarker Quality job in Boston, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking an Associate Director of Biomarker Quality for a leading biopharmaceutical company located in Boston, MA. As the Biomarker Operational Quality Associate Director, you will collaborate closely with business and quality partners to define and advance processes and capabilities for effective and proactive management of risks across biomarker and IVD development activities.

Job Responsibilities:

Partners with biomarker validation and in vitro diagnostics (IVD) development functional leaders, teams, and quality partners in designing and delivering proactive quality approaches, aligned with global regulatory requirements, industry best practices, and business requirements.
Reviews, advises, and communicates with relevant functional and quality leaders and team on biomarker and IVD development-related quality issues that may have material impact on clinical program delivery and/or regulatory submissions.
Lead the identification of quality risk areas for biomarker and IVD development and processes and works with applicable business and quality partners to define appropriate and pragmatic mitigations.
Provides timely and effective communication of summary trending and other insights on biomarker and IVD process health to relevant business and quality partners and in relevant forums. Supports the delivery of operational governance meetings.
Leads and/or supports inspection readiness activities in collaboration with business and quality partners related to biomarkers and IVD development.
Collaborates with Global QMS and Compliance organization to ensure the maintenance and continuous improvement of appropriate quality systems for IVD development globally.
Serves in an advisory/ consultative role in development of audit strategy for biomarkers and IVD development
Participates in relevant external initiatives and industry forums and translates insights to relevant quality and business partners.

Skills and Requirements:

M.S. and at least 5 years of experience in experience in regulatory, development, or quality assurance for biomarker, IVD, and/or medical product development or a B.S./B.A. in a life science discipline and minimum of 8 years' experience in experience in regulatory, development, or quality assurance for biomarker, IVD, and/or medical product development.
Advanced degree and IVD device experience preferred.
Demonstrated knowledge of and experience interpreting and applying global regulations, guidance, and procedures required for development of biomarkers and in vitro diagnostics
Broad global health regulatory agency knowledge and practical experience interpreting and applying regulations and guidance related to in vitro diagnostics development and biomarker development and validation.
Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model
Excellent communication skills and a proven track record of Influencing/building/promoting a culture of Quality and Excellence
Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment
Broad and deep operational and project management knowledge and experience.

If you are having difficulty in applying or if you have any questions, please contact Jason Lawrence at (+1) 646-779-7968 or j.lawrence@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-JL2