Gary Budney Email & Phone Number | My career in Pharmaceutical Quality and Technical Operations has continually expanded my knowledge across multiple technologies, functions, regulatory requirements and businesses. This comprehensive experience allows me to develop and execute effective quality and operational strategies and processes for delivering sustainable GxP compliance, efficient operational performance, consistent product quality and customer service. I particularly enjoy building and mentoring organizations; building systems and processes; and problem solving.....there is no challenge a talented and motivated team can't handle! Highlights and areas of expertise: ● Quality Operations Leadership. Building organizations and quality systems; site quality head, multi-site and corporate roles; early development through commercial phases. Executive Team member and BOD accountability for GxP compliance. ● GMP Remediation. FDA Consent Decree & Warning Letter remediation planning and execution; inspection readiness and management. Strong credibility with regulatory authorities. ● Quality Management Systems. Quality Manual / Quality Board / Management Reporting & Metrics / Risk Assessment and Mitigation / Policies and Procedures. ● Supplier and Third Party Quality Assurance. Suppliers / CMOs for critical raw materials, API, drug products, laboratory services, packaging and distribution; Clinical QA for CROs; US, Europe and Asia locations. Quality Agreements and collaboration on Supply and Master Service Agreements. ● Manufacturing plant management. Leadership for manufacturing operations, engineering, technical services, safety and customer service. ● Technology Transfer and Validation. New plant start-up and 20+ product transfers (APIs, Drug Products) all with successful pre-approval inspections. Qualification of ex-US facilities for US FDA product approvals. ● GxP Computer Systems Validation & Implementation. Corporate (multi-site) LIMS; ComplianceWire LMS, Veeva Vault, Master Control, JDEdwards, TrackWise. 21 CFR Part 11 and data integrity strategies and controls. ● Products and Technologies: solid orals: coated & uncoated tablets; low dose hormones; IR & SR tablets & capsules; softgels; non-sterile APIs; semi-solids: ointments, lotions, creams, suppositories; oral solutions & suspensions; sterile injectable solutions; inhaled aerosols; transdermal patches. Brand, generic, OTC and nutritional product lines. ● Corporate Compliance Officer supporting risk management for Manufacturing, Quality and Research Divisions; Corporate Lead for DEA compliance and business continuity.

Gary Budney

My career in Pharmaceutical Quality and Technical Operations has continually expanded my knowledge a...
13 Hickory Drive, Chester, United States

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Gary Budney’s Email gary.budney@arvinas.com

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Gary Budney’s Location 13 Hickory Drive, Chester, United States

Gary Budney’s Current Industry Cardurion Pharmaceuticals

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Work Experience

Cardurion Pharmaceuticals

Vice President - Head Of Quality

2023-07-01 00:00:00 - Present

Arvinas

Executive Director - Quality

2020-09-01 00:00:00 - 2023-04-01 00:00:00

Achillion Pharmaceuticals

Vice President, Head Of Compliance & Quality Assurance

2017-03-01 00:00:00 - 2020-09-01 00:00:00

Iroko Pharmaceuticals

Vice President Quality

2014-05-01 00:00:00 - 2017-02-01 00:00:00

Purdue Pharma

Director Supplier Quality Assurance

2013-06-01 00:00:00 - 2014-02-01 00:00:00

Corepharma

Vice President, Quality Operations

2009-12-01 00:00:00 - 2013-06-01 00:00:00

Schering Plough

Vice President, Global Compliance

2004-03-01 00:00:00 - 2009-12-01 00:00:00

Warner Chilcott

Vice President, Quality Operations

2003-10-01 00:00:00 - 2004-03-01 00:00:00

Cardinal Health

Vice President, Operations

2002-01-01 00:00:00 - 2003-01-01 00:00:00

Watson Pharmaceuticals

Vp Quality Operations

1996-01-01 00:00:00 - 2001-01-01 00:00:00

Warner Lambert

Sr. Director, Quality Operations

1995-01-01 00:00:00 - 1996-01-01 00:00:00

Rhone Poulenc Rorer

Director, Quality Assurance / Quality Control

1987-01-01 00:00:00 - 1993-01-01 00:00:00

Skills

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Languages

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FAQ About Gary Budney

Gary Budney is located at
13 Hickory Drive, Chester, United States

Gary Budney is a My career in Pharmaceutical Quality and Technical Operations has continually expanded my knowledge across multiple technologies, functions, regulatory requirements and businesses. This comprehensive experience allows me to develop and execute effective quality and operational strategies and processes for delivering sustainable GxP compliance, efficient operational performance, consistent product quality and customer service. I particularly enjoy building and mentoring organizations; building systems and processes; and problem solving.....there is no challenge a talented and motivated team can't handle! Highlights and areas of expertise: ● Quality Operations Leadership. Building organizations and quality systems; site quality head, multi-site and corporate roles; early development through commercial phases. Executive Team member and BOD accountability for GxP compliance. ● GMP Remediation. FDA Consent Decree & Warning Letter remediation planning and execution; inspection readiness and management. Strong credibility with regulatory authorities. ● Quality Management Systems. Quality Manual / Quality Board / Management Reporting & Metrics / Risk Assessment and Mitigation / Policies and Procedures. ● Supplier and Third Party Quality Assurance. Suppliers / CMOs for critical raw materials, API, drug products, laboratory services, packaging and distribution; Clinical QA for CROs; US, Europe and Asia locations. Quality Agreements and collaboration on Supply and Master Service Agreements. ● Manufacturing plant management. Leadership for manufacturing operations, engineering, technical services, safety and customer service. ● Technology Transfer and Validation. New plant start-up and 20+ product transfers (APIs, Drug Products) all with successful pre-approval inspections. Qualification of ex-US facilities for US FDA product approvals. ● GxP Computer Systems Validation & Implementation. Corporate (multi-site) LIMS; ComplianceWire LMS, Veeva Vault, Master Control, JDEdwards, TrackWise. 21 CFR Part 11 and data integrity strategies and controls. ● Products and Technologies: solid orals: coated & uncoated tablets; low dose hormones; IR & SR tablets & capsules; softgels; non-sterile APIs; semi-solids: ointments, lotions, creams, suppositories; oral solutions & suspensions; sterile injectable solutions; inhaled aerosols; transdermal patches. Brand, generic, OTC and nutritional product lines. ● Corporate Compliance Officer supporting risk management for Manufacturing, Quality and Research Divisions; Corporate Lead for DEA compliance and business continuity.

Gary Budney currently works in the Cardurion Pharmaceuticals |

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Gary Budney has prior
experience in the following industries:
Arvinas | Achillion Pharmaceuticals | Iroko Pharmaceuticals | Purdue Pharma | Corepharma | Schering Plough | Warner Chilcott | Cardinal Health | Watson Pharmaceuticals | Warner Lambert | Rhone Poulenc Rorer

Gary Budney has the following professional experience:
Cardurion Pharmaceuticals | Arvinas | Achillion Pharmaceuticals | Iroko Pharmaceuticals | Purdue Pharma | Corepharma | Schering Plough | Warner Chilcott | Cardinal Health | Watson Pharmaceuticals | Warner Lambert | Rhone Poulenc Rorer