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Joann H. Pyle acclzg@r.postjobfree.com ● 717-***-****

JOANN H. PYLE

**** ****** **, ***. **** Oceanside, CA 92057 ● acclzg@r.postjobfree.com ● 717-***-****

PROFESSIONAL SUMMARY

Compliance Professional with extensive pharmaceutical, vaccine and nutrition industry experience working in

various aspects of the business in both plant manufacturing and corporate environments. Strong analytical and

detail-focused approach. Background includes supervisory, project management and team leadership abilities.

Flexible team player with excellent interpersonal and collaboration skills. Received company awards for

demonstrated leadership, collaboration and strong work ethic. Areas of proficiency:

Quality Agreements SOP, technical & legal document

o o

writing/negotiation writing/evaluation

GMP, GCP, ISO, ICH compliance Consent Decree/commitment

o o

implementation

Document management/control

o

Supplier and internal partner

o

systems

relationship building

PROFESSIONAL EXPERIENCE

GENENTECH, INC. Oceanside, CA

Senior Quality Specialist, QA Site Compliance (2013 - present)

Implement QA Site Compliance initiatives ensuring site inspection readiness.

• Coordinate /participate in internal or partner audits and regulatory inspections.

• Work with key stakeholders to establish appropriate CAPA resulting from internal audits and track to

closure.

PFIZER INC. (Formerly Wyeth), Collegeville PA

Supplier Quality Manager, Nutrition Global Quality Operations (2010 – 2011)

Facilitated the Global Nutrition Supplier Quality Management Program initiatives.

• Partnered with corporate and site Quality and Procurement colleagues to optimize supplier qualification and

performance across the Nutrition network. Negotiated global Quality Agreements with various global

suppliers.

• Initiated and implemented standard business processes, tools, and systems to support supplier management for

selecting, qualifying suppliers, supplier performance monitoring programs (CAPA).

Quality Systems & Documentation Manager, Nutrition Global Quality Operations (2008- 2010)

Performed review and approval of GMP documentation and product labeling and facilitated the quality and

technical documentation lifecycle management process.

• Managed the electronic document/records management control systems which included creating, reviewing,

editing, approving, publishing and archiving of all GMP-related documentation for the business unit.

• Ensured that master formulas, label claims, purchase specification/testing standards, test methods and SOPs

comply with regulatory guidelines and corporate policies/procedures.

• Evaluated nutritional product labeling information for various global markets.

WYETH, Collegeville PA

Contracts Analyst, Clinical Contracting Group - Corporate Legal Division (2006 to 2008)

Served as legal analytical support to corporate attorneys and Clinical R&D and Global Medical Affairs teams.

• Prepared, reviewed and negotiated various types of contracts for clinical studies (e.g. CDAs, Clinical Study

Agreements, IOP Agreements) as per corporate policies and procedures and regulatory guidances.

• Managed the process and workflow of numerous contracts spanning various therapeutic areas (e.g.: women’s'

health & bone, pain management, immunology, asthma/allergy, metabolism, neurology, cardiovascular, and

oncology); tracked contract status in electronic database and provided detailed reports to teams and Senior

Management.

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Joann H. Pyle acclzg@r.postjobfree.com ● 717-***-****

Principal QA Specialist I, Global Quality Operations (2004 to 2005)

Special assignment to the Quality Agreement Program Office to resolve problem global Quality Agreements

through drafting and negotiation with various suppliers for the Pharmaceutical, Vaccine, Consumer Health Care

and Nutrition business units.

• Wrote/revised Quality Agreement templates (APIs, Excipients, Critical Processing Aids, Primary and

Secondary Packaging Materials, Dietary and Nutritional Ingredients) in accordance with applicable

regulations and quality standards (USP, EP, NF, IPEC-Americas, ICH Guidelines and FDA 21 CFR).

• Provided QA support with the development of a global supplier qualification and management system

(objectives and System User Specifications) and drafting of related Conformance Standards and SOPs.

WYETH, Marietta PA:

QA Compliance Manager/Principal QA Specialist I, QA Audits and Compliance (2002 to 2004)

Accountable for external and internal GMP quality/compliance monitoring program activities.

• Established and maintained the site Quality Agreement Program. Acted as Project Lead for Consent

Decree commitment for establishing Quality/Technical Agreements (Q/TA) with all third-party

contractors/suppliers.

• Served as QA representative on site Supplier Review Team; evaluated new suppliers/contractors for

compliance with qualification requirements and resolved related quality issues.

• Ensured the audits of suppliers/contractors per schedule. Participated external audits and resolved

supplier audits/inspections related compliance issues and investigations. Maintained supplier

documentation files.

• Participated in internal audits to ensure compliance with applicable regulatory requirements; produced

and tracked audit commitment reports through closure.

QA Clinical Project Specialist, QA Release Office (2000 to 2002)

Provided quality assurance support to Research & Development project teams and ensured compliance with GMPs

relative to clinical trial material manufacturing and release.

• Evaluated, wrote, revised manufacturing procedures, SOPs/forms, validation protocols/reports and

procedure deviation reports; reviewed production processes; and issued clinical release protocols.

• Participated in FDA and other regulatory inspections and external compliance audits. Audited internal

processes, quality systems and project activities to ensure compliance with GMP regulations.

• Served as Qualified Trainer for QA Release Office Clinical Research & Development Support personnel.

QA Analyst V, QA Record Review Section (1996 – 2000)

Reviewed clinical trial material and commercial product manufacturing batch records and QA/QC records for

accuracy, completeness, legibility and compliance with SOP, cGMPs and product specifications.

• Reviewed labeling and packaging clinical research work orders; recommended disposition clinical trial

material shipments.

• Maintained plant change-control records and SOP Manuals and prepared completed GMP-related records

for archival.

OTHER RELEVANT EXPERIENCE, WYETH (MARIETTA, PA; 1990-1996)

Held positions of increasing responsibility in Production Support Services and Quality Assurance as Component

Preparation Operator, Biological Service Operator, Manufacturing Technician, Section Supervisor and QA

Analyst.

EDUCATION

Master of Science, Pharmaceutical Quality Assurance and Regulatory Affairs (2000)

Temple University, School of Pharmacy, Fort Washington, PA

Bachelor of Arts, Government and Political Affairs; minors in Business and History (1993)

Millersville University, Millersville, PA

CERTIFICATIONS

Certificate of Achievement: Manufacturing & Supplier Quality Assessments Phase I, Pfizer Auditor Training

Program (2011)

Certified Quality Auditor, American Society for Quality (ASQ; 2003, 2006, 2013)

Qualified Trainer, Wyeth Trainer Qualification Program, ‘one-on-one’ and group training (2001)

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Joann H. Pyle acclzg@r.postjobfree.com ● 717-***-****

Paralegal Certificate Course Program, Millersville University, Millersville, PA (1998)

AWARDS

Nominated: President’s Achieving Excellence Award (10/2003), Consent Decree Commitment QSE 24 (Quality

Agreements with Contractors/Suppliers)

Above and Beyond Award (09/2003), Quality Agreements Project Team Leader, Wyeth Vaccines

Recognition Award (07/2003), Supplier Review Team, Wyeth Global Vaccines

Special Recognition Award (11/ 2001), CAIV-T Project Team, Wyeth-Ayerst Research

Above and Beyond Award (05/2001), RSV Project Team, Wyeth-Ayerst Research

TECHNICAL PROFICIENCY

PC/Mac, Microsoft Office, Novell/GroupWise, Outlook, Gmail, SharePoint, LiveLink, TrackWise, electronic GMP

document control systems (EDMS, ensur3.0) contract/agreement management systems, SAP (ERP) applications

and LIMS.

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