Quality Assurance Management

To Whom It May Concern:

I would like to highlight some of the experiences that I believe make me

highly qualified for any position of leadership and responsibility in the

area of quality assurance/quality systems:

. 28 years of broad drug development experience, including 16 years in a

leadership role in quality assurance, 4 years in the preparation of

Chemistry, Manufacturing, and Controls documentation, and 8 years in

the development of analytical methods.

. Significant experience in the design, hands-on configuration,

validation, training, and administration of corporate-wide Quality

Systems, including SAP for inventory management and quality

management, Trackwise for deviations, investigations, corrective

actions, and change control, Documentum for document workflow and

mangement, and numerous other electronic and paper systems for

Standard Operating Procedures, Laboratory Information Management,

Training, and administrative purposes.

. Extensive experience as author, reviewer, and approver of divisional

policies and departmental standard operating procedures. Developer of

many forms, templates, and databases for a variety of technical and

business processes.

. Responsible for performing trend analysis of quality incidents and

corrective actions and for reporting the results and conclusions to

senior divisional management.

. Significant experience at leading and participating on teams for drug

development and computer systems implementation.

. Significant experience providing training and preparing training

materials.

. Strong skills in information/document management, communications, and

presentations.

. Ability to multi-task, detail oriented, dependable, comfortable

working hands-on.

. Strong familiarity with cGMP regulations for US, Canada, and EU.

. 19 years of direct or indirect supervisory and coaching experience,

with as many as 8 direct reports.

This is just an overview of the broad experiences I have had in my career

in drug development. I would welcome the opportunity to discuss my

qualifications in greater detail.

Sincerely,

Clifford Sachs

PROFESSIONAL SUMMARY

Senior Quality Assurance professional with 28 years of demonstrated

leadership, progressively increasing responsibility, and broad, hands-on

experience in drug development. Significant expertise in the disciplines

of Quality Assurance/Quality Systems, CMC Regulatory Documentation, and

Analytical Research and Development. Experienced in quality oversight of

GMP activities and development of quality management systems, SOPs, and

documentation standards to assure compliance with U.S., Canadian, and EU

GMP regulations for clinical supplies. Additional expertise in the

preparation of CMC Regulatory Documentation, development and documentation

of Analytical Methods, Information/Document Management, and Training.

Expert in strategic thinking, project management, and problem solving.

Excellent communication and relationship building skills. M.B.A -

Pharmaceutical Studies; B.S. - Chemistry.

PROFESSIONAL EXPERIENCE

VALIDANT STRATEGIC CONSULTING, San Francisco, CA 02/2010 - Present

Performing Quality Assurance consultation in support of the remediation of

a major international pharmaceutical manufacturer for compliance with

regulations for FDA and Health Canada. Implementing enhancements to

systems for Deviations, Investigations, CAPAs, and Process Validation.

Developing strategies for resumption of manufacturing of products on hold

due to compliance shortcomings or manufacturing issues.

PHARMACEUTICS INTERNATIONAL, Hunt Valley, MD 03/2009 - 11/2009

Private contract manufacturer of commercial and clinical supplies with a

large client base.

Director, Quality Assurance

Reported directly to the Vice President, Quality Assurance. Supervised a

team of 4 direct reports. Partnered with senior management of all other

drug development functions to maximize compliance of GMP operations.

. Made critical contributions to the successful remediation and

recertification for compliance with EMEA regulations.

. Responsible for oversight of all investigations into quality incidents

in manufacturing, packaging, and analytical testing and for monitoring

the satisfactory completion of corrective actions.

. Led the Document Change Control function. Responsible for critical

review, approval, and change management of all quality documents,

including SOPs, specifications, protocols, batch records, and test

methods Provided oversight to administrative staff.

TOBIRA THERAPEUTICS, Princeton NJ 06/2008 - 02/2009

Small, private, start-up, drug development organization, backed by venture

capital investors.

Director, Quality Assurance

Reported directly to the Vice President, Quality Assurance/Regulatory

Affairs. Directed company-wide internal and outsourced GMP activities,

including quality management of contractors, batch document review and

approval, SOP development, and review and approval of investigations and

corrective actions. Partnered with Senior Vice President of Clinical

Development and with Vice President of Pharmaceutical Development in

strategic planning for clinical studies.

. Performed initial and ongoing contractor qualification through

completion of audits, implementation of quality agreements, and review

of batch documents and deviations. Partnered with contractors to

enhance quality and compliance of processes.

. Performed investigations into quality incidents in manufacturing,

packaging, and analytical testing and monitored the satisfactory

completion of corrective actions.

. Developed and managed a new SOP system; developed SOPs for Quality

Assurance functions.

. Partnered with Clinical Development and Pharmaceutical Development to

maximize compliance in the design and implementation of clinical

studies.

. Performed quality review of regulatory submissions and clinical

documentation (i.e., clinical protocols, and Investigator's

Brochures).

. Provided quality support to Project Teams, CMC sub-teams, and Clinical

Development sub-teams.

BRISTOL-MYERS SQUIBB, New Brunswick, NJ 06/1982 - 02/2008

( Quality Assurance/Quality Systems (

Associate Director (2000 - 2008) / Group Leader (1996 - 2000) / Manager

(1994 - 1996)

Reported to the Director of Quality Assurance/Quality Systems. Supervised

and trained a team of 8 direct reports; provided strategic and tactical

guidance to a team of 25 within the department; partnered with senior

management of all other drug development functions to maximize compliance

of GMP operations. Developed, validated, provided training for, and

implemented systems for quality management (TrackWise ), supply chain

resource planning (SAP), laboratory information management, and standard

operating procedures (MS Word/Documentum).

. Led Product Release group - responsible for the review of analytical

data and manufacturing records for internal and contract operations,

and for managing research specifications. Participated in

investigations into deviations from SOPs and/or GMPs in Manufacturing

and Analytical R&D.

. Performed business process assessment, software configuration,

validation, implementation, and administration of the Pharmaceutical

Development Quality Management System (TrackWise ), for managing Alert

Notices and related Investigations, Audits and related Observations,

Corrective/Preventative Actions, Batch Record Review, and Vendor

Qualification.

. Provided instruction and guidance on GMP issues for Analytical R&D,

Process Development, and Dosage Form Development. Represented the

Quality Assurance Department on several task forces, standing

committees (e.g., Method Documentation TQM Team, Impurities

Initiative, Bovine Spongiform Encephalopathy Task Force, Information

Systems User Group, LIMS Implementation Team, Computer Validation Task

Force), and numerous Product Development teams.

. Led pharmaceutical development-wide pre-approval readiness teams (30-

40 team members per project) to prepare in advance of and respond

optimally during regulatory inspections for small molecule and

biologics applications.

. Performed audits of laboratories, warehousing, packaging and labeling,

and drug product manufacturing.

. Determined requirements and performed validation, training, and

implementation of numerous quality systems to improve compliance,

improve productivity, streamline operations, and/or minimize resources

in the management of clinical supplies.

. Reported results and conclusions of quality metrics assessment for

quality incidents and corrective actions to senior divisional

management. Fostered steady improvement in first-pass quality and CAPA

closure.

. Established strategies for managing procedural documents and for

managing alignment of divisional procedures with corporate and

interdivisional procedural documents; reduced number of procedures by

1/3 (reduced from ~1500 to ~1000) by identifying harmonization

opportunities for converting local procedures to global procedures.

. Authored, reviewed, and approved SOPs in support of GMPs. Participated

on committees responsible for Analytical R&D and Clinical Supplies

Operations SOPs.

. Implemented the internationally harmonized Gold Standard method

format; enabled the elimination of an entire writing, editing, and

review cycle in preparing analytical method documents for regulatory

submissions.

( CMC Regulatory Documentation (

Documentation Scientist (1992 - 1994) / Research Scientist (1990 - 1992)

Reported to the Director of Quality Operations. Supervised and trained a

team of 2 direct reports; provided strategic and tactical guidance to

over 50 analytical chemists in the preparation of method and validation

documentation for CMC regulatory submissions for Oncology, CNS,

Cardiovascular, Anti-Infective, Anti-Viral, and Diagnostics compounds,

including small molecule and semi-synthetic active pharmaceutical

ingredients.

. Supervised and coordinated the generation of analytical method

documentation and validation reportsfor worldwide regulatory dossiers.

Critically reviewed the technical content and format of these

documents.

. Served as a major technical information resource for worldwide

regulatory actions, which included the assembly of information

required to formulate responses to inquiries from regulatory agencies.

. Authored and reviewed Analytical R&D Standard Operating Procedures;

devised and recommended mechanisms for compliance to and improvements

in GMP, GLP, Safety, Waste Minimization, Communications, and other

technical and administrative policies and procedures.

. Provided critical evaluation, comments, and approval of GMP

documentation for Pharmaceutics R&D, Process Development, and

Diagnostics R&D.

. Provided technical guidance to Analytical R&D and Scientific

Information Systems for the evaluation of computer hardware and

software.

. Supervised and trained other Analytical R&D staff working on

regulatory documentation; reviewed clinical manufacturing, packaging,

and labeling records for GMP compliance.

( Analytical Research & Development (

Assist. Research Invest. (1988 - 1990) / Research Assoc. (1985 - 1988) /

Sr. Research Assist. (1982 - 1985)

Developed and validated analytical methods for materials sciences, atomic

spectroscopy, and gas chromatography/mass spectrometry. Provided testing

results and investigative evidence in to contribute to the development

and manufacturing of APIs and dosage forms, and determined the API and

metabolite content of body fluid specimens from clinical studies.

. Performed Gas Chromatography/Mass Spectrometry method development and

analysis of body fluid specimens for clinical studies of drug

candidates.

. Performed physical characterization of drug substances, intermediates,

and excipients and performed compatibility studies of pharmaceutical

formulations and packaging components by various techniques,

including: Powder X-ray Diffraction, Thermal Analysis, Particle Size

Determination, Scanning Electron Microscopy, Surface Area Measurement,

Fourier Transform Infra-red Spectrophotometry, and Atomic

Spectroscopy.

. Managed laboratory space planning for new laboratory facility housing

over 60 analytical chemists, management, and administrative staff,

reporting functionally to Department Head.

( Awards Received (

. Quality Award - development and implementation of a Quality Systems-

based Procedural Documentation System.

. Quality Award - development and implementation of the Pharmaceutical

Development Quality Management System (TrackWise )

. President's Award - SAP Implementation for the Integrated Supply Chain

Initiative.

. President's Award - significant contributions to the AVAPRO

(irbesartan) NDA Filing Team.

. Star Award - development of training curricula for Quality Assurance

staff.

EDUCATION

Master of Business Administration - Pharmaceutical Studies, Fairleigh

Dickinson University, Teaneck, NJ

. Unique program emphasizing the structure, operation, trends, and

regulatory considerations of the pharmaceutical industry.

Bachelor of Science - Chemistry, State University of New York, Binghamton,

NY

. Completed advanced courses in Physical Chemistry, Organic chemistry,

and Instrumental Analysis.

PUBLICATIONS

. H.G. Brittain, C.J. Sachs, and K. Fiorelli, "Physical Characterization

of Pharmaceutical Excipients: Practical Examples", Pharmaceutical

Technology, 1991, 15(10):38-52.

. M.E. Arnold, C.J. Sachs, E. Ivashkiv, M. Jemal, and A. Cohen, "The

Semi-Automated Extraction of Captopril in Biological Fluids with a

Zymark BenchMateTM Workstation for Analysis by GC/MS", Advanced

Laboratory Automation and Robotics, 1991, 7:517-531.

. R. O'Laughlin, E. Cohen, C. Sachs, H. Brittain, and S. Varia, "Effects

of Variations in Physicochemical Properties of Glyceryl Monostearate

on the Stability of an Oil-in-Water Cream", J. Soc. Cosmet. Chem.,

1989, 40:215-229.

. H.G. Brittain, J. DeVincentis, and C.J. Sachs, "Physical Studies of

Thermal Dehydration of Aztreonam Tetrahydrate", National AAPS Meeting,

Orlando FL, 1988.

. R.L. Jerzewski, T.M. Wong, C.J. Sachs, and N.B. Jain, "Effect of Wet

Granulation on Fosinopril Sodium Polymorphic Form", Pharmaceutical

Research, 1987, 4(2).

. H.G. Brittain, C.J. Sachs, J.F. Lynch, K.M. Ogle, and D.L. Perry,

"Spectroscopic Studies of Thermal Decomposition Products of Hydrated

Cerous Oxalate", Inorganica Chimica Acta, 1987, 127:229-236.

. J.F. Lynch, C.J. Sachs, and H.G. Brittain, "Thermal Decomposition of

EU2(SO4)3.H2O Studied by Low Temperature High-Resolution Luminescence

Spectroscopy", Thermochimica Acta, 1987, 109:343-351.

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