Margaret Moran Email and Phone Number

Compliance leader working with global teams, to ensure quality compliance across all business units in accordance with Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) as well as Company standards. ~ Elevating corporate quality oversight and company quality standards by assessing regulatory trends, coaching members of management, peers and other colleagues in compliance issues, and implementing process improvements and ensuring harmonization across sites.~ Directly responsible for GxP training and vendor management teams establishing proactive oversight, communication, and cross-functional engagement. ~ Lead Quality representative for Pharmacovigilance and Clinical Operations regulatory inspections, driving inspection readiness activities and ensuring proper preparation and escalation to leadership on hot topics. ~ Key Quality oversight for quality management systems and incident escalation program, aiding in root cause analysis, defining robust CAPAs, and regulatory reporting. ~ Responsible for global market actions and annual mock recalls, development of quality plans, quality manuals, and quality standards and quality representative for PDMA activities.~ Directing short and long-range functional and personal objectives to assure year-end goals are attained.~ Primary Quality oversight for drug storage and drug distribution licensing.

Managed quality assurance communications with global regulatory agencies, lead inspection readiness efforts, monitored regulatory intelligence for emerging trends and updated corporate policies to maintain Horizon Therapeutics as an industry leader for regulatory compliance. ~ Coordinating responses to regulatory authorities, managing market corrections, removals and recalls, ensuring thorough investigations and root cause analysis to confirm that robust corrective actions are implemented.~ Driving compliance by providing oversight to vendor management programs, leading internal and external audits, developing corporate policies, supporting developmental quality, and enforcing quality standards.

Active leader of the manufacturing quality operations team (24 persons, 8 direct reports) ensuring production support and execution of quality testing for a sterile injectable manufacturing facility – 6 aseptic filling lines with lyophilization and terminal sterilization operations. Simultaneously managed the Critical Systems Quality team (4 direct reports) providing quality guidance and support to the validation, engineering, metrology and maintenance teams. ~ Driving a high focus on increasing employee engagement, by hosting 1:1 meeting with all direct reports, providing development opportunities through onsite and off-site training, facilitating peer to peer recognition, and setting expectations through SMART goals.~ Successfully engaged the Critical Systems Quality team to redesign process flows to meet the needs of production, leading to 24/7 coverage plans, reduced downtime and a 100% cross trained team.~ Currently implementing a new Manufacturing Quality organizational structure to drive real time batch record review and increase quality on the floor presence to ensure GMP compliance. ~ Oversaw quality representation for the $250mil+ facility expansion project.~ Responsible for departmental budget planning, review and management.

Directed the manufacturing quality operations support for a novel dosage form (PharmFilm®) while managing 10 persons over 3 shifts, 24/7. Concurrently managed the quality systems team with 5 direct reports, who were responsible for multi-site company compliance efforts and all commercial and development pharmaceutical drug product release. Successfully managed the quality relationships with clients performing review of all client documents – deviations, IQ/OQ/PQ protocols, annual product reviews, and QA agreements. Led all client regulatory interaction (i.e. field alert reports) investigations and communication.~ Successfully redesigned the quality operations team to improve efficiency and implemented an On the Job Training (OJT) Program for Quality Operations personnel to increase colleague accountability, ultimately leading to reduced downtime with a 100% cross trained team.~ Drove a Quality System compliance initiative; Achieved 100% compliance in Periodic Review of SOPs, 100% compliance in CAPA Effectiveness Checks and > 80% reduction in overdue CAPAs.

Directed a team of 9 validation contractors while scheduling and managing all validation activities (utilities, equipment, process, and cleaning) at two locations. Responsible for departmental budget planning, review and management.~ Successfully managed the on-time qualification of a secondary production site resulting in full FDA approval.

Sole Validation Engineer onsite responsible for scheduling and managing all validation activities (utilities, equipment, process, and cleaning) at two locations as well as managing workload and responsibilities for validation contractors.~ Successfully validated off-site process and cleaning validations of lyophilizers at contract manufacturer site.~ Ensured proper validation assessment of changes for all quality documents (change controls, risk assessments batch records and SOPs).~ Participated as Validation representative during customer, corporate and regulatory audits. Responsible for determining corrective actions to validation related findings and developing audit responses.

Oversaw all aspects of cleaning validation (CV) and performance qualifications (PQ) to include protocol preparation, scheduling, execution, and final report preparation for regulatory filings. Approver for deviation investigations ensuring thorough root cause analysis and adequate corrective and preventive actions.~ Validation Team Leader for a critical process transfer: maintained execution schedules, meeting rigid deadlines with error resolutions, approved validation documentation for Regulatory Affairs to support EU and US filings, hired and managed a team of 3 contractors.~ New Equipment/Parts Washer team member: provided support during cycle development and FAT testing prior to successfully validating and implementing a small parts washer and plate and frame washer.~ Change Control Review Board member: evaluated new and existing facilities, services, equipment and processes for compliance with GMP regulations.

Performed timely and accurate batch record review to facilitate on time critical care drug product release.~ Partnered with the manufacturing team to provide deviation investigation support as well as trend analysis of execution and documentation errors to promote process improvement.

Performed developmental work for Plasma Fractionation, specifically Fraction IV-1 Extraction studies.~ Successfully determined a suitable viral filter replacement using downscale virus removal studies.

Developed skills in both EPA and DOT regulations and exemptions for the safe transport and disposal of hazardous materials.~ Provided accurate identification and proper segregation of known and unknown chemicals, completed health and safety contingency plans and achieved a Class B CDL, with Hazardous Waste endorsement.