Christopher Santarcangelo, MS

** ******* **.

Milford, CT 06461-9135

Home: 203-***-**** ace6xs@r.postjobfree.com

Cell: 203-***-**** (preferred)

SUMMARY

A Quality and Corporate Compliance director that has successfully developed, implemented, and managed quality

and compliance systems including FDA quality systems, standard operating procedures, auditing, monitoring,

investigations, training, documentation practices, corrective and preventive actions, and interpretation of laws and

regulations governing quality and compliance. Worked in various sized organizations from start-up biotech

companies to multi-national corporations. Strong background in auditing. Strong communication and influencing

skills proven by successful execution of quality and compliance audits. Experienced in sterile and aseptic

processing. Experienced compliance resource in multiple business areas. Ability to evaluate the impact of minor

process changes on entire systems and the associated compliance risks.

PROFESSIONAL EXPERIENCE

Tower Laboratories, Ltd., Centerbrook, CT Present

Sr. Quality Director/Quality Consultant

Manage Quality Assurance and Quality Control for medium-sized pharmaceutical company. Responsible for all

aspects of GMP compliance and regulatory interaction. Responsible for compliance to 21 CFR 111, 210, 211, and

820. Five direct and 25 indirect reports at three manufacturing facilities.

• Lead Quality Improvement Program in response to FDA and customer audits

• Responsible for all quality functions including:

o CAPA

o Change Control

o Deviations/investigations

o Continuous Improvement

o Validation

o Compliance

Quality and Compliance Consulting, Milford, CT 2013-2014

Consultant

An independent quality and compliance service offering support during three phases of program maturity:

• Building – Build and implement quality and compliance programs

• Growth – Enhancing existing programs and executing program elements

• Evaluate – Audit and monitor quality and compliance systems to assure ongoing compliance with

regulations, standards, and voluntary compliance obligations

ProPharma Group, Overland Park, KS 2012-2013

Sr. Compliance Project Manager/Principal Consultant

Manage, lead, and execute projects related to regulatory and corporate compliance. Projects have included:

• Implemented quality system elements for medical device company leading to ISO 13485 certification

• Developed and delivered internal training programs on corporate compliance and ethics, and performing

investigations

• Developed retrospective validation protocols for animal vaccine manufacturer

• Performed process validation gap assessments for API manufacturer and identified specific remediation

actions required for re-qualification

• Performed quality system audits

• Performed Consent Decree Quality Assurance review of laboratory instrument qualification documents

• Provided compliance consulting for medical information service

• Participated in other in-house activities:

o Safety Committee

o Co-chair of Quality Committee

o Manage internal process improvement program (investigations)

Purdue Pharma L.P., Stamford, CT 2003-2011

Assistant Director, Corporate Compliance (2006-2011)

Manage, lead, and execute auditing, monitoring, investigations, and engagement of Independent Review

Organization in Compliance with Corporate Integrity Agreement. Published Monthly and Quarterly reports for

Senior Management Team. Managed three indirect reports.

• Project lead/Business Owner of the Purdue Ethics and Compliance Management System (GRC System) to

manage compliance training, investigations, and auditing/monitoring assessments. Led multi-functional team

of 15 during implementation. Negotiated multi-year license renewal to assure ongoing savings of up to 20%.

• Assisted in negotiations of Corporate Integrity Agreement (CIA) including provisions for auditing and

monitoring and successfully implemented monitoring programs that have led to successful reviews.

Developed and managed monitoring programs of Medical Information function leading to successful

compliance reviews by Independent Review Organization and OIG

• Established Corporate Compliance Audit program; performed, led, and managed audits and follow-up

activities

• Developed and managed monitoring programs for Sales Force Monitoring to successfully identify compliance

gaps resulting in significant remediation actions to assure ongoing compliance

• Implementation and management of Call Note Monitoring program to routinely review free-text call note

entries to identify improper promotion and compliance to Purdue promotional policies

• Produced routine and ad-hoc compliance reports for senior Purdue management for identification and

communication of compliance risks

• Managed annual auditing and monitoring program to assure full compliance with PhRMA Code on Interactions

with Healthcare Professionals

• Compliance Lead on team that successfully implemented electronic promotional material review program to

remediate gaps identified by internal and external audits

• Oversaw Corporate Quality programs for GMP auditing and product quality complaint management.

Sr. Manager, GMP Compliance (2005-2006)

Sr. Compliance Specialist, GMP Compliance (2003-2005)

• Established Corporate Quality GMP Compliance group including two direct reports. Authored multiple policies

and standards to establish consistent guidelines across the company for various quality systems including

Training, Investigations, Auditing, CAPA, and Management Reporting.

• Established and led audit program and maintained schedule for manufacturing sites, API facility, R&D facility

and Supplier Quality Program to assure GMP compliance. The successful program led to several zero-item

483’s and a status of No Action Indicated at manufacturing sites.

• Managed Quality Systems Compliance Manual including the implementation of Quality Polices and Standards

that assured standardization of quality systems across manufacturing facilities, supplier quality programs,

analytical development, and pharmacovigilance/product quality complaints.

• Reviewed CMC documents for regulatory submission to assure compliance with FDA, EMEA and other

regulations

• Tracked and reviewed completion of CAPA of external audit commitments (FDA, EMEA, etc.) to assure ongoing

GxP Compliance at manufacturing facilities and supplier quality

• Performed due diligence audits of potential business partners in cooperation with Supplier Quality Assurance

to identify appropriate alternate sources of third-party manufactured products

Protein Sciences Corporation, Meriden, CT 2002-2003

Quality Control Manager

Managed QC Laboratory for a small biotechnology company specializing in Baculovirus Expression Systems to

produce research antigens and clinical biotechnology products including managing two direct reports. Laboratory

included Microbiology and Molecular Biology testing to support in process and sterility testing of products as a

contract manufacturer and proprietary products.

• Managed chemical safety program

• Led team of 3 scientists to complete analytical method validation

• Multiple indirect reports in various areas of responsibility (safety, wastewater permitting/testing, cleaning

validation, media fill validation).

Bayer Corporation, West Haven, CT 1996-2002

Various positions of increasing responsibility in Quality Assurance. Safety Lead for Quality Assurance Laboratories

(65 analysts and managers).

• Raw Material testing/disposition

• GMP Investigations

• Product Quality Complaint analysis

• Cleaning Validation

• Analytical Method Validation

• Laboratory/Manufacturing equipment qualification

• Computer system validation

• Part 11 remediation

Watson Foods, Inc., West Haven, CT 1994-1996

Analytical chemist responsible for testing of vitamin/mineral premixes used in food fortification.

Volunteer Activity

Boy Scouts of America, Pack 7, Milford, CT 2009-Present

Pack Committee Chair, Den Leader, Cub Scout Roundtable Commissioner

Lead Cub Scout pack of over 20 adult leaders and over 50 scouts. Manage pack operations to assure compliance

with budget, project timelines, and assure leadership positions are staffed to ensure safe and successful program

execution. Utilize communication, influencing, delegation, project management, to assure program meets BSA

requirements to protection of youth and scouting while planning and conducting safe and fun activities. Assure all

leaders are appropriately registered, screened, and trained. Unit received 2011 Gold Journey to Excellence award.

Lead monthly training meetings for Cub Scouts Leaders within local district.

• 2014 District Award of Merit

• 2012-2013 Pack Committee Chair of the Year

• Awarded Wood Badge (2011) – BSA’s premier leadership training program, that includes training on

communication, team building, project management, delegation, conflict resolution, and problem solving.

• Received Tiger Leader Training Award, 2011; Cub Scout Den Leader Training Award 2011

EDUCATION

MS, Management, Albertus Magnus College, New Haven, CT

BS, Chemistry, Rensselaer Polytechnic Institute, Troy, NY

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