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Mark L.

Sakitis
msakitis@aol.com
Piscataway, NJ 08854
(908) 458-7949
Summary:
Results-driven Pharmaceutical/Medical Device Quality and Compliance Professional with expertise leading
global companies in development, implementation and operational support for quality systems and programs.
Accomplished Manager partnering with business stakeholders achieving company objectives. Excellent
technical, interpersonal and communication skills, dealing with organizations across cultures at all levels by
fostering relationships, motivating and empowering teams. (www.linkedin.com/in/MarkSakitis)

Skills/Expertise:
Audit Management. Lead SME in audits / inspections
Data Integrity Assessments and Governance
Driving science based technical decisions across organizations
Governing and managing Global Investigation/CAPA Programs
Global and Sites business processes harmonization/standardization
Laboratory Systems: LIMS, CDS, SDMS, Instrumentation
Metrics-KPIs Development/Management
Policies, Directives and SOP Document Management
Problem and Incident Management
Program & Project Management Methodologies & Tools
Quality Management Systems: EDMS, ERP, CMMS, TrackWise, LMS
GAMP5- Risk-based Approach for Computer Systems Validations
Root Cause Analysis Methodologies & Tools
Supplier and Contract Management, including Quality Agreements and Service Level Agreements
System Lifecycle Management (Concept-Retirement)
In-depth knowledge of both domestic and international regulations, with significant audit hosting experience
(21 CFR 210, 211, 820, Part 11, Annex 11, FDA, EMA/EU, MHRA, ICH and other global regulatory
agencies)
Training on auditing, cGMP regulations, quality systems, root cause analysis and validation

Career Highlights/Key Accomplishments:


Created a global Quality and Compliance Electronic Systems department overseeing regulatory compliance
for all enterprise computer systems improving the quality of validation deliverables and decreasing
inspection observations.
Developed and implemented a First Quality Program for 28 Technical Operations manufacturing sites
driving continuous improvements reducing monthly deviations, investigations and CAPAs by 15-20%.
Led the ISO 9001 certification process for 2 medical device companies authoring Quality
Manuals/Procedures and collaborating/communicating with Senior Management resulting in enhanced and
sustainable effective Quality Systems.
Managed over 30 Contract Manufacturer Organizations (CMOs) for medical devices and OTC products
performing tech transfers for products, process validations and product releases.
Established and managed a Partners in Excellence Program for CMOs eliminating low performing suppliers
with annual savings of $200K per year.
Harmonized and streamlined numerous IT, R&D and Technical Operations CSV documents resulting in a
single standardized risk-based approach with enhanced accountability and ownership for all 3 divisions.
Led global teams in the development and implementation of many new enterprise electronic computer
systems establishing compliant user/functional requirements, system/business ownership roles while
streamlining and harmonizing business processes/workflows.
Validated and implemented a statistical process control software program for monitoring inspection
attributes saving the company $100K per year and reducing rejections.
Led the development and improved organizations IT Controls for outsourced service providers adherence
and compliance to companies policies and health authority regulatory requirements.

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Mark L. Sakitis
msakitis@aol.com
Piscataway, NJ 08854
(908) 458-7949
Professional Experience:

Bristol-Myers Squibb (New Brunswick/Skillman, NJ) 1997 - 2017


Throughout my 20 year career at BMS, I have held the following Quality Management positions working for both
the pharmaceutical and medical device divisions.

Associate Director, Quality and Compliance Global Quality Systems and Programs: (Oct 2006-Apr 2017)
Associate Director, Worldwide Quality Policy and Operational Support: (Jan 2003-Oct 2006)
Manager, Worldwide Quality and Compliance-Continuous Innovation/Statistics: (Oct 2000-Jan 2003)
Manager, Quality ConvaTec division: (Apr 1997-Oct 2000)

Ensured that Quality Systems supporting BMSs global manufacturing and laboratory operations continue to
meet or exceed health authority regulations and evolving expectations.
Managed the Global Quality and Compliance department that provided auditing, incident/inspection
management and validation oversight for all enterprise computerized systems.
Served as the project lead for the Global Investigation and CAPA program. Was accountable for developing
and implementing the global business process and ensuring significant events were thoroughly and
effectively investigated and corrected in a timely manner.
Designed, developed and issued key performance metrics such as Audit Observations/CAPA closure time,
Right First Time, Lots Attempted/Rejected, invalidated OOS and product quality complaints for quarterly
Senior Management Quality Council meetings.
Led and performed Quality Audits (internal and supplier) supporting BMS annual audit schedules and
tracked all audit observations and CAPAs to closure.
Managed the Global Quality training program establishing role based curricula requirements.
Established an effective Quality Risk Management program across all sites utilizing a risk-based approach
for auditing, testing and validation.
Led and participated in cross-functional teams to evaluate new or evolving health authority regulations (i.e.
FDA metrics, data integrity) for compliance and formulated/articulated BMS responses.
Authored and issued Corporate Policies and Directives for Deviation/CAPA Management, Annual Product
Reviews, Change Control Management, Medical Device/Combination Products-Design Controls, Supplier
Audit Management, Management of Quality Agreements, Product Transportation, Risk Management,
Sampling Programs and Validation/Qualification to support evolving health authority regulations.
Managed all Medical Device CMOs performing product transfers, product release, quality audits and
establishing quarterly scorecards based on quality/supply chain metrics for CMO performance

International Technidyne Corporation (Edison, NJ) 1992 1997


Manager, QA/QC

Lead escort for all health authority and ISO facility inspections.
Developed company Quality Manual, authored and implemented numerous procedures for alignment with
ISO 9001 certification requirements.
Managed the Incoming Inspection, In-Process Inspection, Metrology and Product Release Quality
departments maintaining an annual budget of $1.5-1.8M.
Organized and led companywide Management Review meetings with Senior Management establishing
quarterly metrics for manufacturing sites performance.
Experienced in facilitating Kaizen types of events implementing technical solutions for electronic change
controls and document management.
Led and performed FMEA, FTA and DoE for new product development, process improvements and root
cause analysis.
Coordinated and led ISO 9001 and GMP training program.
Managed and performed ISO 9001 Internal and Supplier Audits ensuring compliance to company policies
and health authority regulations.
Investigated customer complaints determining root causes and implementing effective CAPAs.

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Mark L. Sakitis
msakitis@aol.com
Piscataway, NJ 08854
(908) 458-7949
EATON Corporation/ AIL Systems, Inc. (Deer Park, NY) 1984 1991
Engineer, Quality Systems

Designed and developed computer software programs for automatic test equipment.
Investigated and conducted tests for the analysis of digital, analog, and solid state components to determine
their reliability to meet their design specifications.
Generated and maintained the calibration records and documentation of electronic test equipment used in
Government contracts.
Prepared product analysis reports and presented them to Senior Management relating to various defects
and their corresponding corrective action.
Established and maintained manufacturing records, label control systems, manufacturing test procedures
and other documented policies to support AIL's Total Quality Management (TQM) facility.
Participated on inter-department teams responsible for developing new products and proposals for the
military.

Education:
State University of New York at Stony Brook 1982 - 1984
B.S. in Electrical Engineering
Nassau College, Garden City, New York 1979 - 1981
A.S. in Engineering Science

Professional Affiliates/Certifications:
Membership with ASQ, ISPE, IVT
ASQ-Certified Quality Engineer
ISO 9000 Certified Lead Auditor
PDA Certified Computer Supplier Auditor
BMS Yellow Belt Certification and Project Management Certification
TrackWise Administration, Configuration and Crystal Report Design Certificates
21 CFR Part 11 Compliance and SaaS/Cloud Applications Certificate
Green Mountain QA Certificate Advanced Data Integrity Training/Auditing

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