Meghan O'Connell Email & Phone Number

Westford, MA, US

Paris, FR

• Managed product release process (including API, DS, and DP) of biologics.
• Reviewed and approved Certificates of Analysis and Certificates of Complaince for API, DS, and DP.
• Provided guidance during internal investigations for CAPAs, events, and other non-conformities.
• Performed supplier audits (CMO, domestic and international).
• Managed QA team of five, successfully improving their performance in the midst of rapidly changing requirements.
• Reviewed and approved labeling for clinical studies.

Boston, Massachusetts, US

• Managed MDSAP recertification audit resulting in 0 nonconformities.
• Managed the CAPA system, including working with various stakeholders to resolve stagnant CAPAs.
• Implemented streamlined training program that reduced training burden by 20%.
• Developed plan to improve and streamline eQMS workflows to serve multiple sites and multiple business units.

Cambridge, Massachusetts, US

• Developed and implemented a Quality System roadmap compliant with 21 CFR 211 and 820.
• Led development of an Agile based Software Development Process compliant with 21 CFR 820.30 and IEC 62304.
• Led cross-functional team on selection and implementation of an eQMS solution.
• Managed supplier and vendor quality, negotiated Quality Agreements, and conducted audits to 21 CFR 58 and 211.
• Provided input to Regulatory for submission of pre-Subs, IDEs, and Annual Reports.
• Performed drug substance and drug product batch reviews

Acton, Massachusetts, US

• Led team that transitioned from ISO 13485:2003 to ISO 13485:2016, leading to a zero-nonconformity assessment audit.
• Key member of team that transitioned from a paper based QMS to an electronic QMS.
• Led Quality aspects for the planning and implementation of a fully automated production facility.
• Delivered interactive Design Control training sessions.
• Developed Quality staffing plan for new production facility.
• Represented Quality interests in determining optimum layout of new production facility.

Salem, NH, US

• Implemented a two-year Operations Master Planning process driving continuous improvement initiatives.
• Managed several FDA audits resulting in zero findings.
• Managed staff of 5.
• Managed Quality budget.
• Implemented IEC 62304 compliant software development process.
• Led effort to design, validate, and deploy Part 11 compliant Complaint Management System.

• Assisted in scale-up of manufacturing operations.
• Partnered with suppliers to resolve quality issues.
• Led ETO sterilization batch release.
• Performed vendor audits and complaint investigations.
• Implemented quality systems to support initial commercial manufacturing.

US

• Overhauled QMS system to address FDA Warning Letter, leading to clearing of Warning Letter.
• Implemented new Complaint Handling and Investigation system, leading to decreased complaint rate.
• Reduced consumable failure rate from over 5% to less than ½%.
• Assisted in producing 510(k) submissions.

Wilmington, MA, US

• Led Quality Control activities, including product release testing.
• Management Representative for ISO activities.
• Performed system level failure analysis and led software and product validation efforts.

Waltham, Massachusetts, US

Salem, NH, US

Malvern, PA, US

North Chicago, Illinois, US

Waltham, MA, US