Greg Williams Email & Phone Number

Provide GxP quality compliance support for biologics, medical devices, and pharmaceuticals. Support includes inspection preparation, inspection management, compliance remediation, process improvements, audits, and management consulting. Utilizing the company-developed concept of Compliance through Simplicity, our focus ensures that proposed actions are GxP-compliant and streamlined to minimize risk while allowing a simpler compliance pathway.

Suzhou, Jiangsu, Cn

As the Executive Director, Global Quality Systems, Compliance, Audit, Training, and Computer System Validation with Innovent Biologics, I established and optimized the global quality compliance and audit program through development and implementation of processes covering internal and external operations. Performed SME preparation and inspection readiness activities for company’s ex-China submissions. Hired, onboarded, and developed QMS, Compliance, Audit, Training, and CSV professionals. Ensured global quality management system (QMS) were robust, comprehensive, and efficient for meeting regulatory requirements and expectations across the enterprise. ► Established the global quality audit program and combined existing audit processes at site and departmental levels. The resulting organization reduced total budgeted headcount by 25% while exceeding the audit plan by 20%. Implemented global auditor qualification and training program for full and part-time auditors.► Established the global compliance program to ensure oversight and utilize mitigating actions to identify and reduce risk to the patients and company.► Upgraded the quality systems through addition of ex-China market requirements (EU and US). ► Ten-week on-site inspection preparation in China covering all GMP operations across the product flow. Led SME rehearsals, GEMBA walks, and extensive risk identification and mitigation activities to ensure site readiness.► Successfully completed remote interactive evaluation from the US FDA.

Basel, Baselstadt, Ch

As the Head, Global GMP Quality Audit with Novartis, I spearheaded the global GMP and CAR-T quality audit program by devising the strategic direction, establishing priorities, and executing the plan covering all operations across Novartis and external business partnerships. Performed due diligence assessments and Mock PAI, Pre-qualification, Verification, and Routine GMP audits. Hired, developed, and ensured employee engagement of GMP Auditors, Regional GMP Audit Heads, and contractors. Quality System ownership of the internal audit, external audit, and self-inspection programs. Led internal steering committees creating and overseeing best practices related to quality standards audits, assessments, and implementations of new acquisitions. Created monthly metrics related to timeliness of actions and audit program results. ► Reorganized the company-wide audit program combining all GMP and CAR-T audit functions into a single organization while right-sizing overall headcount by 25%.► Planned, executed, reported, and monitored ~1,100 GMP audits per year, leading a global cross-divisional team of 52 Associates in direct reporting line and 125 in matrix reporting line.► Exceeded annual audit plan by 8-10% per year without adding headcount.► Implemented remote auditing program in response to the COVID-19 pandemic resulting in a shift of 45% of the audit plan to off-site execution.► Modified the CAR-T audit program in the US and expanded the program into Europe and Asia.

Basel, Baselstadt, Ch

As the Head of Audit, Group Compliance and Audit with Novartis, I chartered the quality audit program governance of the GxP plan across the organizational structure covering GMP, GCP, GLP, GDP, and PV consisting of more than 2500 audits per year. Mobilized a team of GxP auditors and audit planners throughout the year to implement a consistent and robust audit plan. Co-led the corporate Audit, Compliance, and Risk Forum creating and monitoring results, assessing risks, and evaluating regulatory changes. Served as the corporate Quality System Owner/SME for the audit and self-inspection programs. ► Improved audit effectiveness through changes to planning and execution processes using multiple Kaizen process excellence events.► Improved re-audit frequencies by identifying and monitoring shared audit targets to reduce duplicates and accelerate the pace of audit planning while decreasing audit change requests by 30% – execution averaged 5-10% more audits than planned. ► Redesigned the auditor training and tracking program to implement fast-track certification program, revise tools, and classify auditor skills related to education, experience, training, and languages.► Instituted travel program enhancements saving $100K+ per year in travel cost.► Implemented training for multiple topics, including data integrity, medical devices, computer system validation, Mock PAI auditing, and sterile manufacturing.

Geneva, Switzerland, Ch

As the Vice President, Global Quality Operations, Surgical with Alcon, I advanced and led the quality operations strategy at 10 global Surgical manufacturing sites to assure medical device compliance and attainment of customer expectations across the product lifecycle from development through the end of product life. Surgical products included long-term implantable devices, computerized surgical equipment requiring installation and service, surgical packs, and other surgical accessories and disposable products. ► Led Surgical Quality Operations division of 350+ Associates with annual QA budget oversight of $32M+ across the 10 locations meeting budgetary targets for the franchise with annual sales of $3.7B+.► Implemented site quality risk assessments to identify needed mitigation actions at the site, franchise, and global levels.► Reduced compliance and business risks through reductions of 20% in compliance and CAPA backlogs, and 15% in recurring deviations while reducing franchise inventory by $1.4M.► Pioneered a simplification program to streamline policies, procedures, and processes while implementing global systems for change control, CAPA, and design control to establish international structured programs and ensure consistency. ► Enhanced product quality and quality systems by launching improvement plans for selected sites.

Geneva, Switzerland, Ch

As the Head, Quality Systems, Standards & Affiliates Quality Assurance with Alcon, I championed the global strategic direction for the Alcon Division of Novartis, including all sites, facilities, and Affiliates related to the Quality Management Systems (QMS), External Standards Management, Training, and Distribution Quality Assurance. Served as Deputy Global Management Representative for Alcon and the single point of contact between Alcon and the Notified Body.► Integrated CIBA VISION into the Alcon QMS and Alcon into the Novartis QMS through the Novartis Standards Committee preparing, reviewing, and approving documents as the corporate point of contact for Alcon and CIBA. ► Established the Country QA and the Distribution QA organizations, setting budgetary needs, creating and implementing applicable quality manuals, implemented a monthly global metric program, and hiring associates.► Implemented process improvement processes for device history records, self-inspections, line clearance, labeling controls, record retention, and inspection reduction. ► Ensured the review and identification actions needed due to changes to external standards, regulations, and guidance documents across the Alcon business.

Geneva, Switzerland, Ch

As the Director, Global Quality Management Systems with Alcon, I led the GMP, GLP, and GDP maintenance, review, and improvement of the global quality management systems. Led the R&D quality assurance activities in compliance with Good Laboratory Practices (GLP).► Consolidated 37 EN ISO 13485 certifications into a single global certificate encompassing all sites allowing for a 67% reduction in annual surveillance audits from the Notified Body.► Maintained and improved the global QMS program in compliance with regulations and standards including EN ISO 13485, Canadian MDR, Japan PAL, Australian TGA, and US FDA.► Implemented a LEAN initiative to reduce and simplify global quality system procedures.► Implemented quality manual for non-ISO certified Affiliate locations across the company.

Geneva, Switzerland, Ch

In these roles at Alcon, I led Corporate GxP (including GCP, GDP, GLP, and GMP) audits of departments/sites in the network across the product lifecycle for this Pharmaceutical and Medical Device company. Provided compliance support and strategic leadership associated with inspections, registrations, and post-marketing actions. Extensive domestic and international travel experience across five continents. ► Led 25+ GxP audits per year of global sites, critical suppliers, and key vendors assessing for compliance with company requirements, government regulations, guidance documents, and standards.► Led regulatory and compliance activities, such as drug/device listings, state and federal facility registrations, US Customs clearance, product recalls and other field actions, inspection management, and audit/inspection trending. ► Facilitated global Health Authority inspections for all GxP areas and coordinated CAPA responses, as needed. Inspections included pre-approval, routine, and for-cause.► Led the quality and compliance portion of due diligence assessments of potential mergers and acquisitions. ► Conducted training for quality and compliance topics, including the facilitation of the global Quarterly Compliance Forum.

Geneva, Switzerland, Ch

See duties listed under Assistant Director, Corporate Regulatory Compliance role.

Geneva, Switzerland, Ch

See duties listed under Assistant Director, Corporate Regulatory Compliance role.

Irvine, California, Us

As a MENTOR – Engineering Manager with Mentor Worldwide LLC, I created, maintained and executed the validation master plan, led engineering activities in support of CAPAs, process and product changes and design control projects, and represented the company in health authority inspections and Notified Body audits.

Malvern, Pa, Us

As the Quality Assurance Manager with JOHNSON & JOHNSON's LifeScan, I led the global QA activities for the SureStep product line for this Class II medical device manufacturer. Drove the investigation and elimination of overdue compliance risks in complaints, out-of-calibration, CAPA, and deviations. Implemented operational excellence projects to create a new CAPA program and reduce overdue actions.

Irvine, California, Us

At Mentor, I progressed from Senior Quality Engineer to Plant Quality Assurance Manager. Managed and led the site’s 85+ QA and QC Associates, including Quality Engineers, QC Supervisors, Complaint Handling personnel, and QC Inspectors for this Class III medical device facility. Extensive experience working under FDA Consent Decree remediation to rewrite the QMS system. Represented Quality as a member of the Material Review Board, the CAPA Review Board, and Design Control projects. Implemented programs for cosmetic defect identification and reduction, quality inspection reduction, statistical problem-solving, and supplier evaluation. Facilitated multiple Health Authority inspections, Notified Body audits, and audits by the expert consultants. Conducted supplier audits for the facility.

Watford, Hertfordshire, Gb

At Smith + Nephew, I progressed from Quality Inspector to Quality Engineer II, while providing support and problem-solving for this Class II/III medical device manufacturer. Successfully implemented a statistical process control (SPC) program and stations across the manufacturing lines for instruments and hip, knee, trauma, and spinal implants. Extensive experience utilizing design of experiments (DOE), process capability studies, and Failure Modes and Effects Analysis (FMEA) to improve processes and reduce defects. Tracked and reported supplier performance and led improvement projects. Conducted site-wide SPC training for all operators, applicable support functions, and management.

Bachelor Of Science - Bs, Statistics

Master Of Science - Ms, Industrial And Systems Engineering

Bachelor Of Science - Bs, Mathematics