Associate Director, Lab Operations Quality Assurance
Company: Disability Solutions
Location: Boston
Posted on: May 3, 2024
Job Description:
About the Job
The Associate Director, Lab Operations Quality Assurance, 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 Associate Director is responsible for oversight and management
of the day-to-day operations of the Quality department in Boston
with a global mindset ensuring continuity across all sites. This
position works with all internal teams. The role works closely
across all levels of a highly motivated and collaborative
organization to ensure the audit activities are executed smoothly
and meet both the pharma partner and Roche's needs.--
The Associate Director directs accreditation activities to ensure
adherence to accreditation and regulatory standards including the
College of American Pathologists, NYSDOH, CLIA, CA, MA, and ISO
15189. As a subject matter expert of laboratory standards, this
role guides key stakeholders in decision making to ensure ongoing
compliance. This position supports the planning and work of
multiple teams with a big picture mindset and is accountable for
achieving all related business goals.
--
Key Responsibilities
- Direct, build, advocate, and enable visibility of quality
processes. Ensure accountability within all areas of the business
unit (pre-analytical, analytical, and post-analytical).
- Serves as member of project teams as necessary with
participation in the applicable forums, providing GxP, CLIA, and
NYS compliance advice and regulatory guidance including the intent
of the regulations to achieve continuous quality improvement and
effective quality monitoring (includes risk
identification/mitigation support for potential and identified
operational issues or deviations).
- Lead and coordinate all audit activities for the College of
American Pathologists (CAP), New York State Department of Health
(NYSDOH), and ISO 15189.
- Maintain strong knowledge of and ensure compliance with
regulatory requirements, to include accrediting bodies, federal,
state, and local requirements as well as Roche policies.
- Lead and coordinate follow up activities related to audit
outcomes including additional audit reviews, meetings with the
functional departments, and engaging in escalation communication
processes on serious audit outcomes.
- Ensure enrollment and effectiveness of Proficiency Testing
programs including performance, result review, and follow up action
if necessary.
- Establish and maintain collaborative relationships with key
stakeholders.
- Engage and coordinate follow up activities related to audit
outcomes including additional audit reviews, meetings with the
Operations departments and/or suppliers and engaging in escalation
communication processes on serious audit outcomes.
- Identify and establish Quality standardization practices in
collaboration with US and EU sites to support product and assay
implementation.
- Builds, develops and updates regulatory and accreditation
policies and procedures in accordance with regulatory requirements,
including the notation of the checklist requirement for all Quality
documents within the Document Control system.
- Advises, educates, and updates the Laboratory Director,
leadership and staff regarding accreditation standards, revisions
in accreditation standards, and regulatory standards and
requirements as identified through internet, literature review,
standard review, and conference resources.
- Plan, lead, execute inspection readiness activities to ensure
the laboratory and vendors are ready for inspection by domestic and
global regulatory authorities.
- Provide guidance to FMI departments on CAPA and nonconformance
investigations including the leading of the QA investigation
team.
- Direct programs or procedures which assure the proper
qualification, calibration, operation and maintenance of laboratory
equipment, the timely data analysis and reporting of trends and the
completion of written investigations in response to unusual or
unexpected results or deviations.
- Lead Root Cause Analysis (RCA), Corrective and Preventative
Action, (CAPA), LEAN, and similar continuous improvement
initiatives with a solution-focused mindset.
- Develop, monitor, and evaluate quality management reports and
metrics to identify trends and performing timely escalation as
appropriate to ensure consistent process for patient-centric
testing, as required.
- Responsible for strategic planning, organizational development,
and operations, directing the work of the QA team.
- Prepare written communications and deliver presentations to
senior leadership as required.
- Assist in special projects, including off site implementations,
and activities as required.
- Suggests changes in working conditions and develops and
establishes measures to improve efficiency and performance of the
laboratory, strives to make the laboratory a model of efficiency,
quality, safety, and service.
- Lead and participate in the development and approval for design
and development documents, quality system procedures, and
laboratory documentation and controls.
- Act as subject matter expert and strategist for audit-related
questions within subject matter area and beyond, including front
room and back room support and management for CLIA, the CAP, NYS,
and pharma partners.
- Effectively collaborate with a fully integrated team to
facilitate the completion of documents.
- Provides training and mentorship to less experienced members of
staff across the
- organization.
- Ensures the work climate/culture within Quality System,
exemplifies our Company's Leadership
- behaviors.
- Oversees laboratory compliance including, but not limited to,
oversight of testing personnel competency execution, laboratory
process training, rotation of PT, and maintenance log
review.
- Serves as a liaison CAP, NYSDOH, other state regulatory
agencies as pertinent.
- May lead remote teams.
- May perform batch review and release, as required.
- May perform material review and release, as required.
- Ability to travel periodically (up to 15%).
- Other duties as required.
--
Qualifications:
Basic Qualifications:
- Demonstrated and proven experience within their area of work
and 8+ years of equivalent professional experience
- 4+ years of management experience
- Typically requires Bachelor's degree or equivalent
experience
Preferred Qualifications:
- Advanced degree in the sciences, engineering, business, or a
related field
- ASCP or MT(AMT) Certification
- ASQ Certification
- Experience supporting a CLIA, QC, and laboratory
- Experience with next generation sequencing methodology;
knowledge of molecular biology
- Experience with IVD, or Medical Device product development,
analytical validation and product approval
- Demonstrated experience in overseeing initiatives and/or
resources dedicated to laboratory safety and associated regulatory
guidelines
- Evidence of practical knowledge of standards and regulations
pertaining to the medical device industry, both domestic and
international
- Demonstrated ability to lead, communicate, interact, and
influence effectively at technical levels across functions
- Demonstrated capacity to work in a fast-paced environment with
strong attention to detail
- Demonstrated history of successfully managing multiple
concurrent initiatives and maintaining one's own workflow
- Demonstrated ability to consistently meet or exceed project
deadlines
- Demonstrated ability to maintain confidentiality of business
and proprietary information
- Demonstrated knowledge of bioanalytical assay development,
qualification, and validation requirements that comply with current
regulatory standards
- Strong collaboration skills with the ability to work with
multiple stakeholders in a matrixed environment and to adjust
accordingly to accommodate changing priorities
- Strong skills in troubleshooting and problem solving
- Strong interpersonal skills that include excellent skills in
written communication, oral communication, collaboration, and
problem solving with other departments and colleagues
- Proficiency in Microsoft Office, Word, Excel, Project and
PowerPoint
- Proficiency in relevant analytical methodology and emerging new
technologies
- Understanding of HIPAA and importance of patient data
privacy
- Commitment to reflect FMI's values: passion, patients,
innovation, and collaboration
#LI-Remote
Keywords: Disability Solutions, Cambridge , Associate Director, Lab Operations Quality Assurance, Executive , Boston, Massachusetts
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