QA Manager

William DeAngelo Tabor

**** ***** ******** ******, ***** Falls, SD 57110

(Mobile) 317-***-****

Email: ***********@*****.***

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Summary of Qualifications:

• Experienced in developing and reviewing Quality systems and Quality/Technical Agreements of Contract Manufacturers • Facilitate major/critical manufacturing and/or laboratory investigations (deviations, OOS, cross-site and cross-functional)

• Experience in organizing appropriate SupplyChain/Regulatory/Laboratory/Technical and Senior Quality Management for issue resolution in a timely manner • Experience in leading internal and regulatory inspections of FDA, DEA, USDA and National Association of Boards of Pharmacy (NABP)

• Six years experience in managing Contract Manufacturers • Review and approve process validation protocols & reports

• Ability to organize and prioritize multiple tasks, work independently or as a team • Contribute to regulatory submissions

(QA Review)

• Demonstrated decision-making capabilities, attention to detail, and ability to trouble shoot and understand technical data • Eight years managerial experience with 4 years of supervising direct reports

• Six years quality oversight for aseptic processing of sterile drug products • 12 years direct Quality experience in pharmaceutical / biotechnology industry

Professional Experience: 09/2007- Present

Manager, Quality Assurance

Novartis Animal Health, Larchwood IA 51241

Main Purpose:

Manage overall functionality of QA program, while playing an integral role in site's operational success and profitability through the early detection of quality deficits, avoiding costly errors. Serve as a quality subject matter expert and member of the site leadership team. Supervise up to 10 direct reports for two manufacturing sites in 8-hour/first shift operations. Maintain direct oversight for approx. $1.0 million quality budget.

Key Responsibilities:

• Oversee and ensure implementation and/or maintenance of Site Compliance plan.

• Serve as a “technical quality/product/process” resource during manufacturing.

• Participate in the development and maintenance of corporate/site policies and procedures.

• Lead Corporate/Regulatory inspections and provide senior management with daily update.

• Support submission and launch of new products and manage all quality related issues to minimize business impact.

• Coach Quality staff on quality systems and best practices to gain knowledge on GMP’s.

Accomplishments:

• Co-Led Regulatory inspection from USDA with zero significant findings.

• Led Regulatory inspection from FDA with zero significant findings.

• Developed and recently promoted Quality staff member.

Professional Experience: 08/2009- 09/2009

Manager, Manufacturing Quality Assurance

Novartis Animal Health, Greensboro NC 27408

Main Purpose:

Responsible for all QA responsibilities, including master batch records review, validation protocol and final report review, investigation report review, MCSR and APR submissions, and establishing processes for effective change management with suppliers. Liaison with internal Regulatory Affairs/Regulatory Compliance and R&D colleagues to support project plans, registration batches, evaluate potential suppliers, participate on external audits, implement best practices in project management, coordinate the assembly of “CMC”/Manufacturing Submissions for new products. Directs the activity of QA Specialist while managing a number of projects.

Key Responsibilities:

• Undertake various QA responsibilities including master batch record review, validation protocol and final report review, investigation report review, MCSR and APR submissions, establishing effective processes for change management with suppliers, etc.

• Working with contract manufacturers from a QA perspective, oversee the process optimization, scale-up and registration batch manufacture for new products including necessary analytical methods.

• Oversee the Stability Database, ensuring that changes made to the database are validated; ensuring a QA check of all data entered and ensures up-to-date data is submitted within the Masers.

• Coordinate and manage with third parties on product defect complaint investigations and that NAH timelines are communicated to these third parties. Assume completion, close-out and provide NAH approval for all investigation.

• Coordinate the required documentation for instituting process changes at all manufacturing/packaging/analytical sites.

• Establish and maintain Quality Agreements with contract manufacturers to insure adherence to Novartis Animal Health requirements.

• Evaluate potential suppliers for new products assessing technical and QA abilities to support development and commercial manufacture.

• Review all batch records and analytical results to insure that all products meet specifications prior to authorizing release into the marketplace.

Professional Experience: 07/2006- 06/2007

Director, Quality Assurance and Regulatory Compliance

Cardinal Health Pharmaceutical Repackaging, OH 43701

Main Purpose:

Managed Quality Assurance and Regulatory Compliance program, monitored regulatory agency activities, and assured company procedures were in place to ensure compliance. Also interacted with Sales/Customers and internal production departments to ensure compliance with policies and procedures.

Key Responsibilities:

• Led quality assurance and regulatory compliance program including development of regulatory related SOPs, in-house and vendor auditing, complaint handling, equipment validation, GMP documentation, GMP/DEA labeling design and set-up, regulatory agency reporting requirements, supervising and training personnel, developing more effective QA procedures, and reviewing FDA/DEA industry trends, adhering to all FDA and DEA regulations and company policies.

• Directly supervised the Manager, Quality Assurance and Regulatory Compliance and responsible for overseeing (12) Quality Assurance Coordinators at two facilities.

• Analyzed, evaluated, and upgraded, as necessary, QA procedures.

• Interacted with Operations to ensure all repackaging operations complies with the cGMPs and other FDA/DEA regulations.

• Evaluated all new business activities for compliance restrictions and requirements.

• Managed in-house and vendor audits for regulatory and cGMP/DEA compliance.

Accomplishments:

• Led National Association of Boards of Pharmacy (NABP) Audit and received accreditation for two facilities from the Verified-Accredited Wholesale Distributors (VAWD) program. The VAWD program provides assurance that the wholesale distribution facility operates legitimately, is validly licensed, and is employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions.

• Led two inspections from the US Department of Agriculture, Division of Food and Safety with zero significant findings.

Professional Experience: 09/2005- 06/2006

Manager, Commercial Quality Assurance

Élan Pharmaceutical Inc. King of Prussia, PA 19406

Main Purpose:

In conjunction with Élan’s Third Party Manufacturers and Distributors, provide quality oversight for the production of solid dose and sterile injectable products at third party manufacturing and distribution facilities.

Key Responsibilities:

• Reviewed and approved all batch records and supporting documentation such as fill, finish, laboratory, sterilization and packaging records, and disposition for release to US and EU markets.

• Authored and reviewed change controls, deviations, procedures, product related investigations, product specifications and quality agreements.

• Lead or participated in third party manufacturer and regulatory audits of drug product, API, and excipient manufacturers. Audits include a thorough review of the site’s production process, batch-releasing procedures, batch record review, and overall compliance to cGMPs.

• Maintained communication of quality issues with third party customers and Élan’s VP of Quality.

• Participate and review quality and technical components of the Annual Product Review Report and Annual Report.

Professional Experience: 08/2000- 09/2005

Third Party Supply Services Quality Control Representative

Eli Lilly and Company, Indianapolis, IN

Main Purpose:

In conjunction with Lilly’s Third Party Manufacturers, provide quality oversight for the production of solid oral dose, sterile injectable, and human biological products at four third party manufacturing facilities.

Key Responsibilities:

• Acted as QC person in-the-plant for seven months on international assignment during the manufacturing of Lilly product released to the US market. Provided QC oversight, assistance and guidance in daily third party operation issues and final product disposition. Responsibilities included: maintaining presence on-site during manufacturing; providing guidance to quality issues potentially impacting (Safety, Identity, Strength, Purity and Quality) of the product, which included the review /approval of seven manufacturing investigations and three laboratory atypical reports with an average turnaround time of 2 to 10 days from review to approval; reviewed all batch records containing on average 300 pages per lot, three to five production event reports (know as deviations), and dispositioned 27 approved lots for release to the US market and reviewed 4 rejected lots.

• Responsible person for global product recall which included determining the amount of lots impacted in the US market, second person verified lot information, communicated with Lilly Outside US packaging sites, reviewed and understood environmental monitoring data from technical investigation team, reviewed 3-Day Field Alert letter for accuracy and completeness of Lilly information, worked closely with corporate QA and all third manufactures involved to determine the root cause. Result, all material was recalled within expiration date due to no boundary was identified.

• Reviewed and approved all batch records and supporting documentation such as fill, finish, laboratory, sterilization and packaging records, and disposition for release to US market.

• Authored and reviewed change controls, deviations, procedures, product related investigations, product specifications and quality agreements.

• Participated in third party manufacturer and regulatory audits of drug product, API, and excipient manufacturers. Audits included a thorough review of the site’s production process, batch-releasing procedures, batch record review, and overall compliance to GMP.

• Maintained communications with third party manufacturers and Lilly Quality management of issues.

Professional Experience: 09/1997-04/2000

Schwarz Pharma Mfg. Inc., Seymour, IN 47274

Quality Control Drug Product Chemist

Main Purpose:

Worked closely with the Quality laboratories, Manufacturing, Materials Management, and QA, to ensure that drug product testing activities are technically sound, meet established specifications and consistently meet established turnaround commitments. Perform any necessary laboratory investigations, process validation testing, and product quality attribute testing.

Key Responsibilities:

• Performed analytical testing of Finished Products, Raw Materials, and Stability samples.

• Met regular production deadlines and perform timely evaluation of laboratory data.

Education:

Bachelor of Science in Chemistry from University of Kentucky with an advanced curriculum in Engineering, August 1997.

In 2009, started Masters in Business Administration (MBA) from Andrew Jackson University.

• April 2004 attended weeklong training in aseptic processing / parenteral manufacturing at UT-Memphis, TN.

• February 2006 attended two day FDA Anti-Counterfeit Drug Initiative Public Workshop in Bethesda, MD

• May 2008 attended weeklong IICAB training in scientific principles of vaccines and vaccination and of the USDA regulatory process for assuring the purity, safety, potency, and efficacy of veterinary biologics sponsored by USDA in Ames, Iowa

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William D. Tabor

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