Quality Assurance Manager

Joan E. Sanger

Cellular: 804-***-****

E mail: ****.******@*****.*** 3514 Edgefield Road Greensboro, NC 27409

Summary

Over 21 years of experience in Quality Assurance/Quality Control in a highly regulated environment, that

supports pharmaceuticals (Rx/OTC), dietary supplements and medical devices. I have a logical thought

process which contributes to efficient operations as well as strong communication skills and ability to

work across various levels of management.

Professional Experience –

Contract Packaging Resources, Inc

Director Quality Assurance (05/12 current)

Position is responsible for the overall quality of products being packaged and released at a rapidly growing

operation. Position is required to work closely with operations, project management and sales to ensure a

smooth introduction of new products and customers. Position manages 3 quality professionals.

• Negotiates Quality Agreements

• Final approver of all documents related to validation activities, investigations and change controls

• Hosts customer audits and issues the respective responses with appropriate corrective action identified.

• Proactively identifies areas for improvement and action necessary

• Maintains product quality by enforcing quality assurance policies and procedures.

Fareva, Inc

Lead Investigator – Analgesic/Respiratory Primary Processing Unit (01/12 05/12)

Responsible for administering the manufacturing investigation program, including the preview, expediting,

solving and maintaining the tracking of all investigation reports and commitments.

• Ensures investigations are accurate; identifying and evaluating all processing deficiencies to determine

and classify root cause.

• Proactively initiates actions to prevent or minimize the impact of deviations through observations and

communications with production personnel

• During the investigations, conducts internal audits of manufacturing and packaging operations.

Pfizer (formerly Wyeth)

Senior Manager – Development Quality & Compliance (04/07 10/11)

Hired to streamline activities to support product labeling for new products and/or to revise current labeling

as applicable to maintain compliance with current labeling regulations for Drug Products, Cosmetics and

Dietary Supplements. Additionally, assisted management in establishing a new product development site

for a medical device as well as acting as Product Regulatory Conformance lead for manufacturing facility.

Manager of 4 quality professionals.

• Reviewed/approved SOP’s, investigations, specifications

• Reviewed/approved investigations, change controls, specifications

• Released materials for use in clinical trials

• Acted as the host for various audits, including TUV for CE Certification

• Reduced the backlog of overdue change controls at manufacturing facility within 6 months of hire

• Increased the accuracy of site initiated change controls

• Reduced International review time of site change controls from 68 to 15 days

• Presented metrics at the monthly Site Quality Review Team meeting

• Performed a regulatory review of multiple global submissions to ensure compliance with international

regulations and developed remediation strategies when required.

Principal Quality Assurance Specialist I – External Supply (01/06 04/07)

Promoted into position to support product launches as Quality representative and evaluate potential contract

manufacturers/packagers for new business.

Joan E. Sanger

Cellular: 804-***-****

E mail: ****.******@*****.*** 3514 Edgefield Road Greensboro, NC 27409

• Responsible for PAI Readiness at contractor manufacturing/packaging facilities for NDA products

• Approved all documentation required to authorize final release of new products

• Utilized GMP assessments/Due Diligence audits to identify gaps and appropriate corrective action

• Supported Global Strategy Execution of the top OTC product

• Responsible for defining roles, responsibilities and negotiating Quality Agreements

QA Release Manager–External Supply (10/03 01/06)

Created procedures and processes for investigations, change controls and product release, which created a

virtual department working with Contract Manufacturers and Packagers. This position directly impacted

commercial distribution and was critical in meeting customer and business needs; managed 7 quality

professionals.

Developed professional relationships with Quality Heads at contract manufacturers/packagers and

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defined expectations necessary to meet business needs.

Evaluated supplier’s operational and compliance performance via monthly metrics.

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Identified compliance gaps and assisted in closure planning.

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Actively participated in PAI Readiness programs for successful launches of new products.

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Final approver of all documents related to validation activities, investigations and change controls

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being conducted at contract manufacturers.

QA Release Manager– Consumer Healthcare (06/02 10/03)

This position was located at the Rouses Point, NY facility that employed 1,800 people and involved

streamlining and improving processes and procedures to facilitate the review and release of OTC products,

Joan E. Sanger

Cellular: 804-***-****

E mail: ****.******@*****.*** 3514 Edgefield Road Greensboro, NC 27409

involving both NDA and Monograph Products. This position directly impacted commercial distribution

and was critical in meeting customer needs; managed 5 quality professionals.

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• Reduced batch record errors by 60% by utilizing the record reviewers to eliminate many manufacturing

errors at the source.

• Improved release attainment to 100% from 63% by streamlining the batch record review process,

improving cooperation with production and motivating the release team.

• Reduced new investigations to 46% below baseline.

• Reduced overdue MIRs/LIRs to 60% below baseline

Quality Assurance/Quality Control (06/91 06/02)

Various positions held include Quality Control Chemist, Quality Assurance Supervisor and Compliance

Officer, each with increasing levels of responsibility. Primary functions included:

Approved investigative protocols and the respective reports.

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Checked/approved laboratory testing, scheduled testing to meet customer needs.

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Instrumental in the issuance/approval of investigations in both laboratory and manufacturing

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environments.

Responsible for Market Product Stability Field Alerts, participated in FDA audits.

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Approved/released stability results, NDA stability reports, authored Annual Product Review.

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System Champion for Product Complaints.

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Issued Field Alerts and facilitated investigation teams responsible for determining root cause of the

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stability failures.

Education

Bachelor of Science, Chemistry, May 1991

State University of New York at Plattsburgh, Plattsburgh, NY

Professional Seminars Attended

Mastering Your Performance as a QA Professional

Problem Solving & Decision Making

Conflict Management Skills for Women

Effective Communication in the Workplace

Strategic Leadership Workshop

Joan E. Sanger

Cellular: 804-***-****

E mail: ****.******@*****.*** 3514 Edgefield Road Greensboro, NC 27409

Building Business Partnerships Workshop

Two Day Short Course on Pressurized Metered Dose Inhalers

Understanding FDA’s Medical Device Quality System Regulation

Joan E. Sanger

Cellular: 804-***-****

E mail: ****.******@*****.*** 3514 Edgefield Road Greensboro, NC 27409

Contact this candidate