Validation (CSV, CSA), Audit, QMS, QA/RA, SaMD, Regulatory Compliance

SUMMARY

Results-driven Life Science Consultant with extensive experience in Computer System Validation/Assu (CSV/CSA), Quality Assurance, and Data Integrity within regulated industries. Proven expertise in ensuring compliance with GxP regulations, developing and executing validation protocols, and implementing robust quality management systems. Skilled in identifying risks, conducting audits, and optimizing processes to maintain data integrity and ensure product quality. Adept at collaborating with cross-functional teams to achieve operational excellence and regulatory compliance, while driving continuous improvement initiatives. Strong communicator with a focus on delivering solutions that align with business goals and industry standards.

KEY SKILLS

Stakeholder Management: Maintain regular communication with key stakeholders to keep them updated on project status, risks, and changes. Actively engage them in key project decisions, incorporating their feedback as appropriate. Serve as the primary point of contact to address concerns and manage expectations, ensuring stakeholder satisfaction.

Project Planning: Effective project planning skills in time management, resource allocation, risk assessment, and the ability to define clear objectives, develop detailed timelines, and coordinate cross-functional teams to meet project goals within budget and deadlines.

Team Leadership: Proven leader with the ability to inspire and motivate, skilled at conflict resolution, decision-making, fostering collaboration, and guiding a team toward achieving shared goals while supporting individual growth and accountability.

Quality Assurance: Strong attention to detail, analytical thinking, problem-solving, knowledge of testing methodologies, and the ability to ensure products or processes meet established standards by identifying defects and driving continuous improvements.

Computer System Validation: Proficient in executing Computer System Validation (CSV) processes, including drafting validation plans, performing risk assessments, creating test scripts, and ensuring that systems meet regulatory compliance standards such as GxP, 21 CFR Part 11, and Annex 11, while maintaining data integrity throughout the system lifecycle. Adept at developing and managing the delivery of CSV documentation including Validation Plans, Requirements, Design Specification, IQ/OQ/PQ test scripts, and Validation Summary Reports.

Policy and Procedures: Skilled in developing, reviewing, and implementing comprehensive policies and procedures that align with regulatory requirements, industry best practices, and organizational goals to ensure compliance, streamline operations, and mitigate risks.

Data Integrity & eCompliance: Experienced in ensuring Data Integrity and eCompliance by implementing regulatory frameworks, conducting thorough audits, developing risk-based strategies, and enforcing policies that align with FDA, and other global standards to maintain secure, accurate, and reliable data throughout the system lifecycle.

HIGHLIGHTED CAREER ACCOMPLISHMENTS

Managed high performing global teams who were accountable for final review and approval on GxP SDLC documents including test results to ensuring proper readiness for FDA audits.

Implemented quality management and risk management practices utilizing ALCOA+ principles across multiple organizations.

Led the data integrity culture across global sites, including the training & development of SMEs and championed the data integrity & eCompliance policies.

Hired, trained and managed a global team that advised, developed, and implemented strategies & ensured a continuous culture of compliance that followed the QMS and the data integrity life cycle.

Implemented Agile and Lean methodologies for SDLC validation projects resulting in less defects; 20% reduction in project timelines; and a 25% increase in efficiency.

WORK HISTORY

DataCompliance, Inc. Mar 2024 - Present

Senior Life Science Consultant

Consults clients on continuous improvement of their Computer System Validation, Quality Management, Data Integrity and eCompliance processes.

Leads the development of CSV documentation and testing of computer systems.

Evaluates existing policies/procedures and provide guidance on alignment to regulations. Writes and revises policies/procedures when necessary.

MilliporeSigma Jun 2022 - Mar 2024

Global Director of Data Integrity & eCompliance

Led the implementation of data integrity and e-compliance policies and guidelines across global sites.

Hired and managed a global team that developed and implemented compliance strategies.

Drove the implementation of electronic data lifecycle management in a regulated environment.

Collaborated with cross-functional teams and stakeholders to ensure compliance and mitigate risks.

Strengthened data integrity culture by training SMEs and championing e-compliance initiatives.

Verista Feb 2021 - Jun 2022

Senior Manager

Managed the validation and compliance of GxP systems, ensuring adherence to global quality regulations.

Developed and enhanced validation documentation for SAAS, IT applications, and cloud systems.

Validated innovative global GxP data solutions, resulting in a 25% decrease in reported deviations.

Conducted risk assessments and audits to ensure compliance with regulatory standards.

AstraZeneca May 2014 - Jan 2021

Director of Global IT Quality & Compliance

Global oversight of IT quality strategies, ensuring compliance with FDA, EMA, and MHRA regulations.

Directed the validation of cloud platforms and ensured continuous improvement of IT quality systems.

Reduced development time by 18% through the introduction of enhanced regulatory risk training.

Ensured periodic reviews of GxP system validations and addressed compliance risks.

Bristol-Myers Squibb (Contract) Feb 2008 - May 2014

Senior Manager, IT Validation & Compliance Services

Led validation efforts for innovative platforms, ensuring regulatory compliance across the IT landscape.

Implemented risk-based validation strategies, automating decision-making, and enhancing efficiency.

Collaborated key stakeholders to address quality concerns, reducing rework, and compliance risks.

EDUCATION

Temple University – Business Administration

CERTIFICATIONS & MEMBERSHIPS

Certified on Cybersecurity Foundations: Governance, Risk, & Compliance (GRC)

Member of ISPE & served on regulatory committee

WORKING KNOWLEDGE

Applications/Software: Microsoft Office (Word, Excel, Access), Jira, ValGenesis, and Veeva.

Regulations: GxP, GAMP 5, 21 CFR Part 11, 21 CFR 820, ISO, ICH, IEC, and HIPAA. EU Annex 11

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