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

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