Michael J Cross

Michael J Cross Email and Phone Number

Quality leader in Quality Engineering, Supplier Quality & Validation | Project Management | Change Agent | Team Builder @ Thermo Fisher Scientific
Michael J Cross's Location
Groveland, Massachusetts, United States, United States
Michael J Cross's Contact Details

Michael J Cross personal email

n/a
About Michael J Cross

Accomplished leader with over 25 years of experience in the biopharmaceutical industry. Experience includes building high-performing teams and driving organizational change, playing a critical role with the design and management of the QMS both site and globally, and fostering a collaborative integrated culture with internal and external partners. Recognized for Innovation Leadership by the Biogen executive team.

Michael J Cross's Current Company Details
Thermo Fisher Scientific

Thermo Fisher Scientific

View
Quality leader in Quality Engineering, Supplier Quality & Validation | Project Management | Change Agent | Team Builder
Michael J Cross Work Experience Details
  • Thermo Fisher Scientific
    Site Quality And Regulatory Head, Laboratories Chemical Division, Thermo Fisher Scientific
    Thermo Fisher Scientific Nov 2018 - Present
    Waltham, Ma, Us
    Responsible Quality and Regulatory lead for ISO 9001: 2015 chemical manufacturing and distribution complex servicing pharma, electronic, and research organizations internationally.• Leader of 12 member QA/QC and Regulatory team driven to establish and improve operational, quality, and regulatory policies and systems in a tightly regulated, high volume, customer focused environment• Championing and executing site and global based improvement projects including Trackwise exceptions, mobile computing (handheld scanners technology) and product segregation controls enhancement to satisfy pharma and electronic based industries• Establishing and enhancing Right the First-Time culture through Quality floor presence, GEMBA walks, operations empowerment, visual management tools, and data sharing• Developing new high-tech customer focused product management model including dedicated product specifications and procedures, manufacturing controls, and secondary supplier oversight
    View
  • Amri (Albany Molecular Research Inc.)
    Associate Director, Quality Assurance
    Amri (Albany Molecular Research Inc.) Dec 2017 - Oct 2018
    Albany, Ny, Us
    Leader of the site Quality Assurance team of 14 in a dynamic, expanding CMO environment, responsible for all quality assurance functions for the commercial and clinical aseptic formulation and fill operation in Burlington.• Key member of the Site Leadership team leveraging industry experience and leadership for daily operational decisions and site strategy focusing on compliance, process optimization, and organizational development • Work with the fellow SLT members to develop short and long term operational and organizational goals for the site to address increased manufacturing activity, QMS improvements, and capacity expansion• Successfully championed site initiative to transition paper-based exception and change control systems to Sparta STRATAS cloud-based software solution to meet all global goals• Serve as primary Quality contact for several client program teams and compliance initiatives, immediately achieving step change improvement in customer relations and program success
    View
  • Biogen
    Sr. Manager, Cell Culture Operations And Project Management
    Biogen Nov 2011 - Dec 2016
    Cambridge, Ma, Us
    Manage Cell Culture Project Team, focused on site based process improvement, system management, and metrics reporting for the upstream manufacturing group• Key contributor to Cambridge PMO to establish resource management systems and project prioritization for the Cambridge Manufacturing organization• Responsible manufacturing lead for number one site project for 2016, Automation Next Generation Proof of Concept, establishing implementation and oversight strategy, resource model, and all other aspects required for project implementation success• Established routine forum with site IT Operations to resolve gaps with planning and communication of IT enterprise system upgrades, outages, and infrastructure support.• Primary regulatory inspection lead for dispensary and support areas• Syncade Automated Weigh and Dispense (AWD) Global Lead, providing global leadership and strategic planning for site based MES software distributed to four Biogen manufacturing sites. Drove the Culture of Automation as a component of the Global Automation Strategy• Served as AWD product representative with global senior leadership team conveying utilization metrics, challenges, and strategic vision on behalf of the sites
    View
  • Biogen
    Sr. Manager Cambridge Quality Engineering
    Biogen Aug 2005 - Nov 2011
    Cambridge, Ma, Us
    Lead Quality Engineering team in Cambridge providing Quality system oversight and continuous improvement for systems such as Trackwise Core Change Control, Analytical Instrument Validation, and Product Changeover • Strive for cross-site alignment with the Quality organization globally and foster industry understanding and improvements via cross site initiatives • Lead site Quality re-organization focusing on succession planning, sustainability, and functional alignment with other sites. Ratified by Quality senior leadership and implemented within 6 months• Lead site Top Talent review for Cambridge QA/QC, representing site senior management with global talent review process in global forum (RTP) • Provided site and global Quality leadership for 2010 FDA regulatory response activities, serving as primary operational decision maker for the global response team • Serve as site contact and lead for budget and reforecast activities for Cambridge Quality (2009 -2011)
    View
  • Biogen
    Manager Cambridge Quality Engineering
    Biogen Jan 2003 - Aug 2005
    Cambridge, Ma, Us
    Established a new Quality function in Cambridge focused on the systems governing equipment, utilities, and change control. Assembled a high performing team to enhance and maintain site and global procedures for areas such as cleaning validation, validation exceptions, and product changeover• Collaborated with site Engineering and Validation to develop change control systems for equipment and process changes• Worked with team to lay the ground work for future electronic based change management systems. • Serve as site coordinator for Regulatory Inspections• Worked with global team to implement global process change control system for drug substance
    View
  • Biogen
    Manager Cambridge Quality Assurance
    Biogen Nov 2001 - Jan 2003
    Cambridge, Ma, Us
    Responsible for all operational quality systems in Cambridge, focusing on drug substance and the clinical filling, lyophilization, and packaging operation • Led Quality team in product disposition activities, exceptions management, materials release, auditing, and metrics establishment and reporting• Developed a routine forum to review exceptions and preventative actions for senior management• Led and supported functions such as document review, cell bank release, metrology and environmental exceptions review, and process change control• Quality coordinator and war room lead for regulatory inspections
    View
  • Biogen
    Sr. Qa Specialist/Qa Specialist, Supplier Quality Management
    Biogen Nov 1997 - Nov 2001
    Cambridge, Ma, Us
    Served as primary Quality contact with Avonex commercial contract filler Ben Venue Labs and Tech Transfer lead for commercial filling operations. Independent leadership role responsible for managing all quality aspects of the contract in conjunction with the assigned operations contract manager• Primary on-site Biogen representative for contractor regulatory inspections, logistics activities, and periodic commercial operations reviews with the senior leadership team • Responsibilities included reporting and investigating product and process deviations, batch record review, product complaint investigations, routine oversight of batch formulation and filling on site• Lead the technology transfer of Phase III Biologic to domestic and international contract sites for commercialization. Significant contributions to validation/process protocol, material logistics, and document readiness
    View
  • Charles River Laboratories
    Sr. Quality Assurance Specialist – Contract Manufacturing
    Charles River Laboratories May 1992 - Nov 1997
    Wilmington, Massachusetts, Us
    Primary Quality Assurance contact for all quality systems supporting clinical and commercial contract manufacturing with over 50 clients. During this tenure established full document control system, training program, validation program, materials processing, and customer specific master batch records• Co-host for all on site customer development activities, audits, and regulatory inspections including periodic USDA and FDA inspections and ISO-9002 Registration
    View

Michael J Cross Skills

Quality Control Biotechnology U.s. Food And Drug Administration Gmp Change Control Capa Biopharmaceuticals Fda Validation Team Leadership Corrective And Preventive Action Technology Transfer Standard Operating Procedure Quality System Cleaning Validation 21 Cfr Part 11 Iso 13485 Quality Assurance Medical Devices V&v Fda And Regulatory Inspections Qms

Michael J Cross Education Details

  • University Of Vermont
    University Of Vermont
    Environmental Studies - Self Designed Major Program Focused On Regulatory/Science/Economics

Frequently Asked Questions about Michael J Cross

What company does Michael J Cross work for?

Michael J Cross works for Thermo Fisher Scientific

What is Michael J Cross's role at the current company?

Michael J Cross's current role is Quality leader in Quality Engineering, Supplier Quality & Validation | Project Management | Change Agent | Team Builder.

What is Michael J Cross's email address?

Michael J Cross's email address is mi****@****bal.com

What is Michael J Cross's direct phone number?

Michael J Cross's direct phone number is +161791*****

What schools did Michael J Cross attend?

Michael J Cross attended University Of Vermont.

What skills is Michael J Cross known for?

Michael J Cross has skills like Quality Control, Biotechnology, U.s. Food And Drug Administration, Gmp, Change Control, Capa, Biopharmaceuticals, Fda, Validation, Team Leadership, Corrective And Preventive Action, Technology Transfer.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.