Quality & Compliance Program Leader

LAWRENCE E. ROCK

Boston, MA 617-***-**** ********.****@*****.*** linkedin.com/in/lawrencerock

PROFILE

Quality and Compliance Leader with a proven track record of solving business problems, improving processes, and leading teams across quality, compliance, legal, operations, and patient services. Known for building practical quality programs, reducing risk, strengthening regulatory compliance, and helping organizations work more efficiently while improving patient and customer outcomes.

mQuality Assurance

mGxP Compliance

mAudit Readiness

mInspection Readiness

mRegulatory Compliance

mCAPA

mRisk Management

mData Governance

mPharmacovigilance

mQuality Management Systems

mSOP Management

mContinuous Improvement

mCross-Functional Leadership

mProcess Improvement

mQuality Systems Governance

mFDA Regulations

mDeviation Management

mRoot Cause Analysis

mVendor Quality Management

EXPERIENCE

Vertex Pharmaceuticals Boston, MA

Sr. Manager, Program Quality – US Patient Support COE (Jan 2026 -June 2026)

Led program quality, compliance oversight, and audit strategy across multi-disease Patient Support Programs (PSPs), ensuring adherence to GxP standards, privacy regulations, and internal policies while driving audit readiness, vendor oversight, and continuous improvement initiatives in partnership with Legal, Compliance, and Patient Services teams.

mDirected internal, vendor, and third-party PSP audits using data analytics and performance metrics to strengthen compliance, mitigate risk, and support vendor quality management and targeted training initiatives.

mLed communication monitoring across calls, emails, and text interactions to identify compliance trends, reduce risk, and implement process improvements.

mBuilt and enhanced GxP Event Management frameworks, establishing scalable Quality Management System (QMS) standards, governance controls, and performance measurement systems across multiple therapeutic areas.

mOversaw audit and inspection readiness programs, ensuring alignment with regulatory expectations and enterprise quality objectives.

mPartnered with Legal, Privacy, Compliance, and Business Integrity teams to strengthen quality systems governance and ensure compliant stakeholder engagement.

mDrove operational excellence through process standardization, continuous improvement initiatives, and scalable best practices across programs and disease areas.

Takeda Pharmaceuticals Lexington, MA

Sr. Manager, Patient Services QA – Patient & Market Access (Rare Disease) (Jul 2023 to Mar 2025)

Led enterprise-wide quality and compliance initiatives across global rare disease programs, strengthening data governance, pharmacovigilance oversight, and regulatory compliance while driving audit readiness, remediation strategies, and inspection responses that eliminated major findings in internal and FDA reviews.

mMaintained inspection readiness through SOPs, work instructions, and patient service policies aligned with FDA regulations, achieving zero audit findings and minimal observations.

mReduced late adverse event submissions through targeted training, deviation management, and strengthened compliance controls, ensuring timely one-day reporting and improved inspection outcomes.

mLed transition from paper-based to electronic adverse event submissions via CRM, reducing turnaround time by 40% and eliminating reporting errors.

mStrengthened compliance and patient care delivery by onboarding and training internal staff and vendors, including Syneos Health and Cognizant.

mPartnered cross-functionally with Legal, Compliance, IT, and third-party vendors to resolve compliance issues, align systems, and sustain regulatory adherence across patient services.

Manager, QA & Data Integrity – Patient & Market Access (Rare Disease) (May 2016 to Jul 2023):

Launched the newly established Quality & Effectiveness function, building foundational processes, QA frameworks, and compliance strategies to strengthen transparency, audit readiness, and regulatory alignment across patient services.

mOversaw records and information management for the 10K+-employee U.S. Patient Services function, ensuring proper data archiving, centralized storage, and team training that reinforced audit-readiness and compliance.

mExpanded team capacity by managing a junior analyst, providing leadership and development that improved group performance and operational effectiveness

mRevamped SOPs and work instructions to streamline workflows, improve operational efficiency, and enhance compliance consistency.

mModernized transparency reporting by transitioning adverse event and complaint submissions to digital platforms, improving accuracy, timeliness, and data integrity.

mPartnered with Compliance and Legal to operationalize U.S. and global transparency requirements while delivering cross-functional training to strengthen organizational accountability and compliance awareness.

Nxstage Medical, Inc. Lawrence, MA

Sr. QA Analyst, Pharmacovigilance /End-Stage Renal Care (Jan 2015 to May 2016):

mDirected compliance investigations for post-market surveillance, ensuring adherence to GxP and GMP standards and global transparency requirements while streamlining complaint reporting and regulatory filings to improve timeliness and performance.

m Delivered compliance and transparency metrics to executive leadership and regulatory agencies, strengthening oversight and accountability.

MEDTRONIC Mansfield, MA

Sr. Quality Analyst, Post Market Surveillance/Vigilance, Venous Solutions (Jun 2011 to Dec 2014):

mSupported global compliance and transparency operations by managing post-market regulatory reporting aligned with FDA and International Organization for Standardization standards, strengthening audit readiness and regulatory compliance.

mConducted trend analysis and root cause analysis to identify systemic risks, enhance transparency reporting, and improve compliance performance in audit environments.

Covidien Mansfield, MA

Medical Supplies Account Manager (Oct 2005 to Jun 2011):

mManaged relationships with healthcare providers across assigned accounts and territories, driving product adoption and customer satisfaction.

mPartnered with customers to identify business needs, deliver tailored solutions, and strengthen long-term strategic partnerships.

mConducted product training and education programs that increased customer engagement, improved utilization, and supported business growth objectives.

mCollaborated with cross-functional teams including sales, marketing, operations, and clinical stakeholders to execute customer-focused initiatives.

mAnalyzed customer trends and performance metrics to identify opportunities for growth, retention, and enhanced service delivery.

mConsistently served as a trusted advisor to customers, balancing business objectives with customer success and operational excellence.

EDUCATION

Master of Science (MS) Degree, Administrative Studies – Financial Economics Boston University Boston, MA

Bachelor of Science (BS) Degree, International Business Johnson & Wales University Providence, RI

CERTIFICATIONS

Six Sigma Yellow Belt (Takeda Business Solutions)

Graduate Certificates: HR Management (UMass Boston)

Financial Markets & Services (NE College of Finance)

PROFESSIONAL TRAINING

CAPA Six Sigma Root Cause & Failure Investigation

LEADERSHIP

Co-Founder, The Color of Biotech Massachusetts

Board Member, American Cancer Society - Eastern New England

AFFILIATIONS

Massachusetts Biotechnology Council The Partnership, Inc. Kappa Alpha Psi Fraternity, Inc.

EXECUTIVE LEADERSHIP BRAND

Builds practical quality systems and governance processes that help organizations grow and stay compliant.

Uses data and root cause analysis to solve business problems and reduce risk.

Works effectively with Legal, Compliance, Privacy, IT, Operations, Commercial, and senior leaders to achieve shared goals.

Leads process improvements and system changes that make work simpler, more consistent, and more efficient.

Develops people, strengthens teams, and creates lasting improvements that increase performance.

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