SUMMARY:

• An accomplished compliance and quality assurance professional who excels in driving positive transformations while administering regulatory compliance, risk management, quality assurance, and technical validations.
• Facilitates companywide audits in areas of governance, documentation, procedural controls, and security, monitoring compliance to a range of regulations and requirements at the state, national, and international level.
• Leads employee training and demonstrates expertise in assessing key practices for computer systems used in highly regulated areas such as GMP, GCP, and GLP as well as Medical Device, Eudralex, and ICH standards.Enabled the pioneering of a regulatory - focused global computer systems compliance program, for Confidential / Confidential in order to reaffirm and maintain the company’s credibility and sustained its right to operate.
• Developed, implemented, and streamlined internal policies and procedures, resulting in zero observations for process audits and regulatory inspections; completed upwards of 35 complex audits per year, ensuring compliance to local standards and international regulations for processes used during the development and release of products for drug trials to commercial use.
• Designed and led a training program for auditors and validation personnel on procedural and global regulatory expectations vis-à-vis computer systems.
• Managed relations with all levels of the organization, from C-suite leaders to technicians, addressing issues of non-compliance and quality control in culturally diverse markets with a range of global regulations/standards.

CORE STRENGTHS:

• Stakeholder Relations
• Audit Planning/Management
• Communications
• Data Integrity Regulatory Compliance
• Policy Development
• Process Improvement
• Risk Management
• Remediation Strategies
• Project Management
• Systems Documentation
• Change Management
• Control Assessment
• Data Analysis

PROFESSIONAL OVERVIEW:

Confidential

IT Quality and Compliance Manager

Responsibilities:

• Headed team of validation analysts in managing compliance of all Safety Informatics (Pharmacovigilance) computer systems used by internal and external partners.
• Standardized the IT processes of Roche’s business structure to address current needs; built contingencies to respond to future inspection trends, quality and compliance regulations, and business growth as needed.
• Analysed and interpreted risks according to regulatory requirements, corporate policies, and industry standards; subsequently offered recommendations to pertinent business units.
• Leveraged expertise in operational methods to develop and implement risk and compliance programs that enhanced performance while raising quality assurance for Safety Informatics systems.

IT Quality and Compliance Manager

Confidential

Responsibilities:

• Achieved two successful inspections by the MHRA and two partner audits (with zero inspection or audit findings for safety informatics systems included in the process).
• Communicated effectively with all professional levels, including technical and non-technical staff, conveying concepts, strategies, and updates to business unit leaders to drive successful testing and validation.

Senior Technical Manager (Senior Auditor)

Confidential

Responsibilities:

• Proved integral in conducting global internal and external computer system and GMP audits in full compliance with internationally accepted regulations and standards; completed regular audits at vendors/sites in Asia, Europe, Latin/South America, and across the US.
• Organized and oversaw audit planning and scheduling after evaluating the criticality and risk score of global auditees; also, arranged a comprehensive roster of potential auditees.
• Researched, identified, and formulated strategies/recommendations to address gaps, redundancies, and vulnerability in corporate governance, risk, and compliance.
• Served as Computer Systems Compliance Representative on the global Data Integrity team to identify and formulate strategies and processes to ensure Data Integrity at Confidential /Roche.
• Led internal investigations of compliance issues, oversaw documentation and reporting of findings, reviewed and accepted corrective action plans, and followed-up with stakeholders to ensure proper resolution.
• Served as Quality Representative, providing coaching and technical support on quality systems, processes, and issues; proactively participated in knowledge sharing and problem resolution.
• Penned and submitted GMP and CSV compliance opinions and audit reports.
• Communicated effectively with all professional levels, including technical and non-technical staff, conveying concepts, strategies, and updates to business unit leaders to drive successful inspections and partner audits.
• Set agendas for the audit and coordinated travel plans to ensure all necessary audits were completed on-schedule; led foreign-language audits using software/applications and working with translators.

Clinical Trial Coordinator

Confidential

Responsibilities:

• Served as project coordinator for three drug development trials.

Project Manager

Confidential

Responsibilities:

• Worked on the 21 CFR Part 11 remediation project for all regulated computer systems companywide.