Dir, Quality Assurance - New Product Portfolio
Company: Disability Solutions
Location: Boston
Posted on: November 20, 2023
Job Description:
About the Job
The Director, Quality Assurance (QA) will work as part of a new
product team, focused on improving blood-based cancer diagnostic
capabilities in areas such as cancer detection, minimum residual
disease, and other related applications. This team is comprised of
talent from across the Roche ecosystem, including Roche
Diagnostics, Roche Pharma and Foundation Medicine, operating as a
single unit.
The Director QA is responsible--for the development and
implementation of a comprehensive quality strategy for a new
portfolio of assay products. This role is responsible for quality
assurance activities for associated with this portfolio, both for
centralized and externalized IVDs.-- This program is high priority,
and requires building connections across the Roche organization,
delivering creative and strategic thinking and excellent
communication. This role will have the opportunity to contribute at
the ground level to the overall development and delivery of program
strategy for this new portfolio, provide insights for
decision-making, and lead quality assurance initiatives.
Key Responsibilities
Drive cross-functional collaboration and a culture of
quality:
- Establish strong partnerships with--leaders across Roche,
including, but not limited to, quality colleagues
- Strategically represent Quality Assurance on enterprise
initiatives--
- Contribute as a thought-partner for innovative global
strategy
- Ensure that cross-functional teams are trained and have a
working understanding of internal policies and procedures, and
quality best practices
Optimize and implement fit-for-purpose QMS solutions
- Design QMS procedures to effectively meet business objectives
and meet FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, NYS and other
applicable regulations and guidelines
- Identify, evaluate, and propose tools to implement QMS process
(requirements management, document management, risk management,
etc.)--
- Evaluate pros and cons of different solutions, including
timeline to implementation, cost, resource requirements, and ease
of use--
Lead Quality Assurance activities for centralized and decentralized
IVD development
- Define quality assurance milestones from research phase through
launch for centralized and externalized IVDs--
- Define quality assurance milestones for establishment of a CLIA
laboratory
- Guide Development teams through development and verification
and validation stages of design control
- Lead team through risk management
- Ensure that design, development, verification, and validation
are performed and documented in a compliant manner to support
global marketing authorizations
Maintain Knowledge of Evolving Compliance Landscape:
- Maintain awareness of changing regulations with ability to
assess the impact on projects and make modifications as
necessary
Qualifications
Basic Qualifications
- Bachelor's Degree and 8+ years of demonstrated experience in
device or digital product, pharmaceutical/biologics quality
assurance, or scientific discipline including at least 5 years of
demonstrated experience specifically in quality assurance;
OR--
- Advanced Degree in science, law, health policy, regulatory
affairs or engineering and 10+ years of demonstrated experience in
device, pharmaceutical/biologics quality assurance, or scientific
discipline including at least 4 years of demonstrated experience
specifically in quality assurance work
Preferred Qualifications
- Masters or Advanced Degree in a science, law, health policy,
regulatory affairs or engineering discipline
- 12+ years of professional work experience in a molecular
testing laboratory, diagnostic manufacturing organization and/or a
diagnostics service organization
- 6+ years working in a quality assurance department supporting
globally marketed in vitro diagnostics, including those regulated
by US FDA, IVDD/IVDR, and Japan.
- Experience hosting audits by FDA, PMDA, EMA, CAP, or other
regulatory bodies
- Experience building, optimizing, and implementing quality
management systems that work within FDA device regulations,
IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and guidelines
- Experience building and implementing quality systems within a
CLIA lab especially preferred
- Demonstrated ability to work to drive clarity and deliver
results in the face of ambiguity or a start-up environment
- Must be both an architect AND a do-er, with the ability to
strategize and deliver artifacts
- Experience in multifunctional work environment and ability to
lead development and execution of complex plans across multiple
priorities
- Enterprise mindset
- Ability to influence and negotiate effective solutions through
leading change and driving for results
- Strong analytical skills and ability to apply
strategic-thinking and problem-solving skills to meet business
objectives
- Guiding Development teams on designing, developing, and
validating with quality, risk evaluation, meeting lab and health
authority agency requirements
- Strong focus on applying risk-benefit analyses to solve
problems
- Outstanding presentation and communication skills
- Strong history of achievement demonstrated by leadership
activities and other achievements--
- Collaboration skills and the ability to effectively communicate
(written and oral) with internal and external team members
- Highly effective teamwork and collaboration skills; a team
player
- History of leadership and track record of applying strategic
and systems thinking
- Experience and understanding of both US and ex-US regulatory
registrations, approvals, and maintenance activities
- Understanding of HIPAA, GDPR, and importance of patient safety
and data privacy regulations and guidelines--
- Commitment to FMI's values: innovation, patients,
collaboration, and passion
#OnSite-Flexible--
#LI-Hybrid
Keywords: Disability Solutions, Boston , Dir, Quality Assurance - New Product Portfolio, Other , Boston, Massachusetts
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