Quality Assurance Manager

SUMMARY

Quality leader with experience in global Pharmaceutical, Biotech, Medical Device, Consumer Products and Contract Manufacturing companies. Lead cross-functional teams focused on the development, deployment and execution of comprehensive Quality Systems. Energetic, passionate leader known for detailed approach to business processes and collaboration. Adept at providing practical quality solutions that ensure compliance and enable the business.

KEY COMPETENCIES

Regulatory Compliance Auditing cGMP Training

Site Quality Operations Management Quality Risk Management

Change Control/Change Management Consent Decree Remediation

Regulatory Health Authority Inspection Management Records Retention/Destruction

Batch Record Review/Product Disposition & Release Complaint/Investigation/CAPA

PROFESSIONAL EXPERIENCE

Senior Quality Consultant, Johnson & Johnson - Janssen Pharmaceuticals, Raritan, NJ, 6/2016 - Present

Accountable for management of the Product Quality Complaint Handling process (e.g., label and website related complaints) ensuring comprehensive complaint investigations in partnership with Regulatory Affairs.

Regulatory Affairs Consultant, Johnson & Johnson - Consumer, Skillman, NJ, 7/2014 - 6/2016

Responsible for regulatory changes to various types of consumer products (OTC or Class I, Class II medical devices, cosmetics) following complex FDA regulatory pathways

Evaluated Global Change Controls for regulatory impact and filing requirements

Created, reviewed and approved ingredient lists, product formulas, raw materials and product labeling; prepared regulatory assessments for Approval for Product Releases; prepared and submitted documentation for voluntary cosmetic registrations.

Quality Manager Consultant, Johnson & Johnson - McNeil, Fort Washington, PA, 2/2012 - 7/2014

Provided Consent Decree remediation expertise for the following quality systems: Quality Risk Management, Batch Record Review and Product Disposition, QA Roles & Responsibilities and Sampling Plans and Acceptable Quality Levels (AQLs).

Manager, Quality Systems and Compliance, Pfizer, Pearl River, NY, 6/2003 - 2/2012

Provided Regulatory Compliance guidance for aseptic formulation, filling, and label & pack operations for Vaccines Phase III Clinical Trial Material

Chaired the Change Control Committee and directed the Document Management department ensuring processes were in compliance to applicable standards and regulations

Performed internal audits; facilitated regulatory and third party audits

Documentation Lead for Consent Decree remediation Workplan activities

Routinely met with third party auditors, performed Quality Systems GAP assessments, developed remediation plans, executed deliverables and achieved sustainable compliance.

Manager, NJ Technical Documentation, Schering - Plough, Union, NJ, 2003 - 6/2003

Managed a team of direct reports, including full-time and contractor resources that created, revised and distributed cGMP documents including the issuance of Claritin batch records.

Manager, Quality Assurance Product Release, Cardinal Health, Philadelphia, PA, 2002 - 2003

Directed Batch Record Review, Product Disposition & Release, Change Control and Document Control

Reviewed deviations and related CAPAs ensuring corrective actions were appropriate, timely & system focused

Hosted client audits and responded to deficiencies.

Supervisor, Quality Assurance Document Management Group, Genzyme Biosurgery, Ridgefield, NJ, 1999 - 2002

Managed change management systems for SOPs, batch records, label copy and validation protocols/reports

Quality Assurance Lead for the validation, training, and roll-out of Documentum

Developed Quality Systems for off-site storage, records retention and destruction of cGMP documents

Participated in third party and regulatory audit inspections.

Supervisor, Packaging, Boston Scientific Vascular, Oakland NJ, 1997 - 1999

Managed the sealing, inspection, labeling & packaging operations

Performed physical inventories, cycle counts, SAP roll-out and budgets

Worked with multidisciplinary teams to eliminate $1.2 MM backorder.

Supervisor, Manufacturing, Datascope Corp., Fairfield NJ, 1994 - 1997

Supervised employees in the manufacture of Intra-Aorta Balloons

Supported the transfer and start-up of new facility utilizing Just-In-Time (JIT) manufacturing

Planned manpower and equipment using projected efficiencies to meet production plan

Direct reports and expense budget management.

Johnson & Johnson - Ethicon, Inc., Somerville, NJ, 1978 - 1994

Supervisor, Manufacturing

Managed union and salary employees in the manufacture of custom wound closure products

Team Leader for JIT initiatives which yielded a 40% reduction in cycle time

Improved quality 35%, reduced Quality Assurance headcount 50% by operator certification

Recipient of two Quality Team Awards for improving quality & generating $100k in annual cost reductions.

GMP Coordinator

Escorted FDA auditors during regulatory inspections

Coordinated audit responses, tracked CAPAs to ensure closure and reported status

Developed a comprehensive internal auditing program

Conducted system-based audits to ensure compliance with cGMPs and J&J Standards

Kept management informed of any compliance risks

Developed cGMP training for 500+ personnel.

Supervisor, Quality Assurance

Supervised in-process Quality Assurance technicians to ensure that inspection and testing of products were in accordance with appropriate systems and cGMP regulations

Established SOPs, test methods and product quality standards

Developed technician re-qualification program.

Supplier Representative

Responsible for selecting, auditing and evaluating raw material vendors for Supplier Quality Certification.

Senior Quality Assurance Technician

EDUCATION

MBA, Finance, Fairleigh Dickinson University, Madison, NJ, 1992

BS, Biology, Fairleigh Dickinson University, Madison, NJ, 1982

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