Experience

Obsidian Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, Quality Assurance, Obsidian Therapeutics

  • Sep 2022 - Present

  Cambridge, Massachusetts, United States As a leader in the company’s Quality organization, I work collaboratively with internal and external stakeholders on CMC (internal) and CDMO/CMO (external) teams to assure phase appropriate Quality systems and processes are implemented. • Assure the company and its affiliates associated with the manufacture, packaging, labeling, testing, and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards as well as regulations of… Show more As a leader in the company’s Quality organization, I work collaboratively with internal and external stakeholders on CMC (internal) and CDMO/CMO (external) teams to assure phase appropriate Quality systems and processes are implemented. • Assure the company and its affiliates associated with the manufacture, packaging, labeling, testing, and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities • Conduct clinical product release activities for drug substance, drug product, and /or finished goods for all phases of development including review and approval of Master Batch Records along with executed batch records • Represent Obsidian QA on external CMOs’ project teams. Manage Quality to Quality relationship with CMOs • Assist with establishing and tracking of Quality metrics • Manage deviations, investigations, CAPAs, change controls, OOS, Material Review Boards, product complaints and quality agreements • Assist in preparing or reviewing CMC sections of regulatory submission. • Conduct audits of CMOs/ Testing Laboratories by overseeing vendor management • Provide QA support for regulatory inspections Show less



2seventy bio

• United States
• Biotechnology
• 200 - 300 Employee

• AD Global Quality Compliance

  • Apr 2019 - Sep 2022

  Cambridge, MA Responsibilities included the development, implementation and leading of GMP compliance strategies in alignment with global regulations. • Responsible for internal and external audit program to meet all US, European and global Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements • Responsible for supporting regulatory agency inspections and responding to inspection findings • lead inspection readiness efforts across operations and manage the Auditor… Show more Responsibilities included the development, implementation and leading of GMP compliance strategies in alignment with global regulations. • Responsible for internal and external audit program to meet all US, European and global Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements • Responsible for supporting regulatory agency inspections and responding to inspection findings • lead inspection readiness efforts across operations and manage the Auditor Qualification Program • Manage an efficient and effective risk-based audit program Show less



Pelham Plastics, Inc.

• United States
• Medical Device
• 1 - 100 Employee

• Site head of Quality

  • Nov 2014 - Apr 2019

  Pelham, NH As leader of the company’s Quality organization, responsible to drive strategic direction and ensure the company’s quality objectives are achieved. I also manage and oversee the Quality department including, Quality Assurance, Quality Engineering, Quality Control laboratory, Training, Internal/External Auditing, Packaging and Document Control. • Project lead to transition site from the 13485:2003, Medical devices- Quality management systems ISO standard to the 13485:2016… Show more As leader of the company’s Quality organization, responsible to drive strategic direction and ensure the company’s quality objectives are achieved. I also manage and oversee the Quality department including, Quality Assurance, Quality Engineering, Quality Control laboratory, Training, Internal/External Auditing, Packaging and Document Control. • Project lead to transition site from the 13485:2003, Medical devices- Quality management systems ISO standard to the 13485:2016 standard • Project lead to ensure site wide compliance to 21 CFR Part 820, Quality System Regulation • Directs, manages and maintains the Quality Management System (QMS) including deviations and CAPAs • Oversees and coordinates ISO and customer audit activities. Manages, leads and maintains an internal audit program and schedule • Responsible for sitewide Risk Management program including program training, execution and documentation • Responsible for Supplier oversite and external auditing program. Manages the Supplier Corrective Action Request (SCAR) program. Communicates with suppliers on discrepant product and resolves discrepant product rework or replacement in a timely fashion Show less



Genzyme

• 1 - 100 Employee

• Quality Assurance-Department Head

  • Aug 2011 - Oct 2014

  Cambridge, MA Responsibilities include managing, training and developing a staff of seventeen that are responsible for overseeing all operational aspects of the QA group. This included the QA Ops group as well as the QA Documentation group. • Disposition of two FDA approved products (Epicel and Carticel) • Responsible for customer complaints, risk assessments and deviation/CAPA compliance review, internal audits and closure. Responsible for site wide deviation and CAPAs as well as conducting in… Show more Responsibilities include managing, training and developing a staff of seventeen that are responsible for overseeing all operational aspects of the QA group. This included the QA Ops group as well as the QA Documentation group. • Disposition of two FDA approved products (Epicel and Carticel) • Responsible for customer complaints, risk assessments and deviation/CAPA compliance review, internal audits and closure. Responsible for site wide deviation and CAPAs as well as conducting in depth root cause training • Sitewide administrator for TrackWise • Responsible for the timely review and archiving of batch records, test records, forms and formulation records • Responsible for metric reporting, trending and Periodic Product Review Show less



Pfizer

• Events Services
• 1 - 100 Employee

• Vaccines and CHO Cell Operation’s Manager

  • Sep 2010 - Jul 2011

  Andover, MA Responsibilities include managing, training and developing an Operations staff of forty who are responsible for supporting multiple manufacturing suites. • Monitoring the maintenance of production equipment and facilities in the Manufacturing Suite • Overseeing complete documentation of all required production activities and ensuring compliance with cGMP, SOPs, product licenses, corporate policies and safety practices • Assure that production equipment and facilities are maintained… Show more Responsibilities include managing, training and developing an Operations staff of forty who are responsible for supporting multiple manufacturing suites. • Monitoring the maintenance of production equipment and facilities in the Manufacturing Suite • Overseeing complete documentation of all required production activities and ensuring compliance with cGMP, SOPs, product licenses, corporate policies and safety practices • Assure that production equipment and facilities are maintained in proper working condition and in a validated mode • Interact with Quality Assurance, Regulatory Affairs, Quality Control, Maintenance, Technical Services and Engineering to ensure production targets are met and product complies with cGMP, SOPs, product licenses and corporate policies.

• Compliance and Investigation Manager

  • Jan 2006 - Aug 2010

  Andover MA Responsibilities include managing, training and developing an investigation staff of nine who are responsible for documenting compliant investigations and corrective actions. The team exceeded site goals with an investigation closure rate of greater than 90% while ensuring compliant and thorough investigations • Prioritized, planed, scheduled, and coordinated activities to assure all requirements were completed within required time frames and with the allocated resources. • Advised the… Show more Responsibilities include managing, training and developing an investigation staff of nine who are responsible for documenting compliant investigations and corrective actions. The team exceeded site goals with an investigation closure rate of greater than 90% while ensuring compliant and thorough investigations • Prioritized, planed, scheduled, and coordinated activities to assure all requirements were completed within required time frames and with the allocated resources. • Advised the investigation project teams with appropriate direction, scope and depth. I also mentor staff including Supervisors and Senior Specialists, train staff as necessary to ensure compliance with functional, cGMP, and corporate training requirements • Key player regarding OE initiatives while providing innovation and improvements around investigation • Key player in regards to addressing investigation related questions during regulatory audits egulatory audits