Quality Assurance Manager

CAREER SUMMARY

. Results-oriented and driven professional with solid hands-on and

management experience in all aspects of Pharmaceutical/Biotech Quality

Assurance and Regulatory Affairs (e.g., IND, NDA, BLA, CAPA,

Investigations/Deviations, Contract Manufacturing, Complaints, APRs,

manufacturing quality, development of clinical trial material, etc).

Solid background in Process Validation/Qualification, and Management

of direct reports domestically and internationally. Experienced at

both Pharmaceutical, Biotech, Solid Oral Dose Generic Drugs and

Medical Device industries. Demonstrated competence in Start-ups and

Fortune 500 companies.

. Highly skilled technical Quality professional with 25+ years of

experience Develop, own and manage processes to synchronize

deliverables with internal/external teams and to ensure that

objectives are in line and compliment the company's overall strategies

and long-term goals.

. Resilient hands on manager with proven technical / team leadership

capabilities. Excel in partnering with internal customers and contract

manufacturers/external business partners to effectively communicate

and translate business requirements into achievable and sustainable

technical specifications and quality requirements.

. Possess solid skills in cGMPs/ISO combined with the ability to

decrease compliance risks and deliver expert advice and

recommendations to key internal and external business partners.

. Areas of Expertise

Quality Systems

(QA/QC, cGMP, cGLP, Change Mgmt., CAPA)

Regulatory

(CMC, BLA, IND, NDA, CTD, DMF)

Supplier Sourcing

(RFI, RFQ, RFP)

Regulations

(21CFR820, 21CFR210 - 211, 21CFR600, ISO, ICH)

Engineering

(Technology Transfer, IQ/OQ/PQ)

Cold Chain

(Processing, Transportation)

Supplier Management

(Relationships, Metrics, Qualification)

Contract Manufacturing

(Sourcing, Mgmt.)

Manufacturing compliance

(Audits)

Electronic Systems

(SAP, GxPHARMA, Trackwise, QUMAS and LACES/LIMS)

ACADEMIC BACKGROUND

Master of Science - Quality Assurance/Regulatory Affairs

Temple University School of Pharmacy - Temple, PA - 2006

Bachelor of Science - Biology

SUNY at StonyBrook, StonyBrook, NY - 1979

CERTIFICATIONS

ASQ-Certified Quality Auditor - December 2009

PROFESSIONAL EXPERIENCE

Actavis, Totowa, LLC Aug. 2009 to

Present

Director - Quality Assurance

One of the world's leading players in first-class generic pharmaceuticals

o Site QA leadership; direct FDA interaction (inspection, field alerts)

o Successful third party and FDA inspection resulted in 0 - 483

observations (consent decree site).

o Quality oversight of ANDA submissions/amendments

MannKind Corporation Danbury, CT/Paramus, NJ

Mar. 2007 to Apr. 2009

Director - Supplier Quality/Strategic Sourcing

A biopharmaceutical company focused on the discovery, development and

commercialization of therapeutic products for diseases such as diabetes and

cancer

o Obtained a five-year supply agreement for a critical API.

o Prepared drug substance section of new NDA; quality review and critical

component sections (container closure, novel excipient); ensured the

accuracy of clinical sections; DMF preparation assistance for supplier.

o Prepared SOPs/Quality Agreements required for implementation of new

quality processes.

o Established and monitored quality driven performance criteria for

suppliers; developed and chaired the MRB process.

o Oversaw and monitored the process transfer for manufacture of critical

novel excipient at a CMO and ensured on-time delivery to meet goals for

clinical trial/stability initiatives.

o Participated in technical transfer, process validation at contract

manufacturing sites for dry powder inhaler manufacture.

o Maintained ongoing supply requirements, aligned resources to pursue

alternate sources of API, excipient and device, drove continuous

improvements, drove efforts to improve quality and/or reduce costs, and

support commercial readiness efforts.

Protein Sciences Meriden, CT

Jan. 2007 to Aug. 2008

Consultant

A vaccine company focused primarily on using modern technology to make the

next generation of safer and more effective human and animal vaccines for

influenza, SARS and other diseases.

o Preparation of regulatory documents (BLA) and quality procedures.

Wyeth Pharmaceuticals/Biotech

Apr. 1989 to Nov. 2006

Director/Associate Director/Manager

A global pharmaceutical manufacturer - a leader in vaccine technology

o Increased output of saleable units through the management and transfer of

aseptic fill/finish activities to three contract manufacturing sites.

o Monitored and executed on plans to ensure continuous supply and handle

multiple priorities.

o Brought 4 new vaccine products to market with significant

commercialization value including one which went on to become a

blockbuster product.

o Strategized and prepared the CMC section of BLAs for the licensing of 5

new vaccine products; 2 contract manufacturing facilities; a new

container/closure system (pre-filled syringe).

o Enabled the approval of 2 new contract facility applications without pre-

approval inspections.

o Aided in the design/implementation of new computer systems to support the

business such as SAP, GxPHARMA, Trackwise and LACES/LIMS by approving

design specifications, functional requirements and validation protocols

and reports.

o Direct interaction with CBER, EMEA, MHRA and other regulatory Boards of

Health.

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