Project Manager Compliance

Magda Ingrid Breuer

*****.******@*****.***

ph: 919-***-****

CAREER SUMMARY:

Compliance manager, compliance auditor, investigator, monitor, instructional designer, trainer, policy analyst, technical communicator, and project manager. More than 15 years of practical knowledge and experience in the biopharmaceutical industry, healthcare consulting, and pharmaceutical manufacturing. PROFILE:

• Excellent understanding of compliance and ethical behaviors, compliance methodologies, transparency reporting, interpretation and communication of US and international laws and regulations, audits, investigations, clinical trial requirements, quality, process improvements, monitoring, project management, and training demands and requirements, instructional design, information collection, data and statistical analysis, creating reports and strategic targeted global e-learning training modules and materials, risk mitigation, establishing metrics and standards, data privacy and security, and writing and editing original highly technical and non-technical documentation using GDP.

• Excellent understanding of drug development and application process, process integration and clinical trial requirements, change control, document control, complaint management, OIG Compliance Program Guidance, CIA governance and compliance, 21 CFR Parts 11, 210, 211, 801, 803, 807, 812, 814, 821, FCPA, FDCA, PDMA, HIPAA and security, AKS, FCA, PhRMA Code on Interactions with Healthcare Providers, GAMP 5, CMMI, SDLC documentation, SOX, cGCP, cGDP cGLP, and cGMP.

• Independent, proactive, and motivated leader and team member who exhibits strong written and verbal communication skills, interpersonal and organizational skills and ability to communicate effectively, work under pressure, and meet deadlines. Demonstrated problem solving and negotiating skills, managing competing priorities, ability to discern matters that need to be elevated to senior management and exercising sound judgment. PROFESSIONAL EXPERIENCE:

ROCKET PHARMACEUTICALS

Cranbury, NJ

Manager Supply Chain – Deviations & Technical Writing 05/2023 to Present.

• Deviation and CAPA Management

- Initiate and investigate deviations utilizing the process knowledge and root cause analysis tools and techniques to identify root cause.

- Collaborate and engage with SMEs from Quality Assurance and other functions to assess and analyze deviations and investigations to determine the true root cause, impact, and CAPA.

- Author investigation reports and support/define and implement ‘right’ CAPAs to address the root cause and or contributing cause(s) discovered during the investigation.

- Collaborate and engage with the Quality Management System team to review and finalize monthly and quarterly metrics for the Supply Chain function.

- Support regulatory inspections and responses to observations, including preparatory activities for upcoming inspections related to deviations.

- Created and tracked warehouse and supply chain KPIs to track effective processes, performance, and productivity.

• Change Control Management

- Initiate, own, manage and drive change control and ensure that all related to critical compliance-related activities and key business timelines are progressed through the appropriate stages and decisions are made to support the implementation of the change in a compliant and timely manner.

- Develop and enforce robust implementation plan based on impact assessments performed by SMEs for a given change control.

- Lead, facilitate, and navigate discussions related to change controls to ensure relevant evaluations/assessments and decisions are made in a timely manner with the cross functional teams including but not limited to Product Development, Manufacturing Operations, Manufacturing Science and Technology, Supply Chain, Engineering, Quality Control, and Quality Assurance. Document the decisions and evaluations accordingly.

• Technical Writing Management

- Create and revise cGMP documents, including but not limited to standard operating procedures and forms.

- Lead and coordinate the timeliness for documents including creating, revision, review, approval cycle for cGMP documents and work cross -functionally to delegate documents for review and approval to ensure timely availability of approved and effective version of documents. SUNRISE SYSTEMS INC. (Contractor) at Teva Pharmaceuticals Parsippany, NJ

Project Manager – Specialty Sales Administration

03/2021 to 08/2021

• Directed, coordinated, and reviewed work and progress of assigned personnel for label expansion of vaccine. Oversaw and prioritized daily activities of Teva staff, external contractors, and contract manufacturing organization

(CMO), and reallocated resources if required.

• Monitored, tracked and trended CMO manufacturing tasks using Trackwise, supply chain in-process inventory, and Department of Defense (DoD) supply and shipments. Estimated resource needs and assisted in developing budget projections.

• Scheduled and conducted weekly and biweekly cross functional team meetings with DoD, CMO, external consultants and internal stakeholders to assess project progress and ensure project timelines, benchmarks, milestones for manufacturing and commercializing Adenovirus 4 and 7 is on track.

• Researched marketing strategies of various vaccine campaigns, target population composites, and defined customer portrait, identified buying process, market definition, market map, and leveraged points for label expansion. US TECH SOLUTIONS (Contractor) at Janssen Pharmaceutical Companies Titusville, NJ

Project Manager III-PGHCC (Pharmaceuticals Group Health Care Compliance) 2/2017 to 2/2021

• Supported the design, implementation, and enhancement of an effective ethics and compliance program.

• Reviewed and evaluated new customer-facing pricing and contracting offers inclusive of changes to existing strategies, pricing templates, product terms and conditions, compliance measurement plans, exceptions to pricing template strategies, contract agreements, product terms and conditions, exceptions to customer compliance terms and conditions, Fee For Service arrangements across the contracting continuum with contracted customers or their subsidiaries for effect on compliance with U.S. Pharmaceutical Health Care Compliance Policy Manual, US laws and FDA regulations, GDP, business and operational risks, ability to administer, and validity of business case.

• Managed, led, and executed weekly and ad-hoc Contract and Pricing Committee (CPC) meetings and robust agenda to create dynamic and meaningful discussions between brand team and CPC members regarding commercial pricing strategies, offers, and exceptions and fee-for-service proposal.

• Conducted training for new or delegate CPC members to ensure compliance and understanding with U.S. Pharmaceutical Health Care Compliance Policy Manual as CPC representatives evaluate pricing strategies, FFS arrangements, HECOR and RWE initiatives for their therapeutic or business areas.

• Created, updated, and implemented PGHCC charter, SOPs and work instructions for CPC operation, project plans, set benchmarks, milestones, work streams for each new project.

• Provided HCC guidance and subject matter expertise to the team throughout project implementation and execution. EXECU SEARCH GROUP (Contractor) at Valeant Pharmaceuticals North America (now Bausch Health) Bridgewater, NJ

APR Specialist (Supply Chain)

5/2016 to 2/2017

• Wrote sound scientific technical documents that reflected GDP and accurately captured activities of external drug product manufacturing at contract manufacturing organizations (CMOs) for batch release and logistics, laboratory operations, internal warehouse operations, packing and labeling operations, performed on behalf of Valeant.

• Analyzed, interpreted, reviewed, and coordinated data within QMS from Trackwise, manufacturing records, specifications and controls, deviations and investigations, CAPA, validation activities, equipment qualification, packaging, stability reports, product complaints and adverse events, product returns and salvaged batches, field alerts, and product recalls to create annual product reviews (APRs) and internal SOPs and ensured quality and accuracy of content.

• Participated in internal audits and readiness assessments within QMS to identify issues and control weaknesses.

• Analyzed ICH Q3D general chapters for elemental impurities in drug products to create implementation plan of heavy metal testing in all stages of drug product manufacturing across all CMOs by 2018.

• Managed product complaint samples returned by patients and coordinated sample investigations with CMOs for resolution.

FRESENIUS KABI USA

Grand Island, NY

Investigative Writer – Quality/Production

9/2015-2/2016

• Wrote investigation reports that assessed Trackwise records, initial deviation impact that occurred during manufacturing process to identify issues or vulnerable areas of risk that could impact the company and patients. Communicated and presented findings at DMRB.

• Conducted interviews, reviewed batch records, performed trend analysis, assessed equipment failures, and other incidences in GMP environments that halted production and release of batch lots.

• Wrote final investigation reports that included findings in batch records, SOPs, employee training review, trend analysis, root cause analysis (RCA), investigation findings, CAPA, and impact on product, batches, regulatory process. Provided technical expertise to ensure CAPAs were complete, thorough, accurate, and timely.

• Ensured cGMP compliance with relevant SOPs and performed risk assessments on impact of process deviations on previously manufactured products, current and future products, processes and patient health and safety. BRISTOL-MYERS SQUIBB COMPANY

Lawrenceville, NJ

Compliance Manager – Office of Compliance and Ethics (OCE) 2/2008-12/2013

• Managed and led several interdisciplinary teams and partnered with the law department to collect and interpret functional and operational information to create corporate policies and procedural documents that were comprehensive, cohesive, and consistent, and represented compliance with US and international laws and regulations.

• Led several cross functional teams aimed at improving process integration and efficiency of medical affairs, Quality, market research, and clinical trial management. Recruited SMEs, collected information and partnered with the law department to create corporate directives and business unit SOPs for proper interactions with patients and clinical trial participants focusing on collection of personal and private data, and healthcare providers in accordance with established compliance procedures, HIPAA and other US laws, regulations, principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP).

• Monitored HCPs during live promotional speaker programs for compliance with PhRMA Code and Company policies.

• Investigated alleged incidents of noncompliance with established policies and procedural documents through conducting interviews, tracking, trending, and reviewing records, and performing RCA.

• Audited processes and identified, evaluated, and resolved issues of noncompliance with procedural documents and state and federal healthcare laws, performed RCA, and recommended process changes, if required, and CAPA to mitigate risk to company and patients. Identified problems through analysis of project performance metrics and recommended corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensured completion of CAPAs generated through internal and external audits. Policy Analyst – Office of Compliance and Ethics (OCE) 8/2005 to 2/2008

• Created new or updated existing procedural documents in consultation with the law department for HR, Privacy, IT, Document Control, Commercial Sales and Marketing, as well as Quality compliance, Clinical R&D, supply chain, and EHS for various harmonization activities to ensure alignment with Quality Manual.

• Managed, wrote, edited and implemented corporate and business unit procedural documents that reflected GDP, managed day-to-day corporate procedural compliance responsibilities, and ensured procedural documents for GMP, GCP, and GLP process improvement initiatives were created and developed using accurate and timely information regarding US and international laws and regulations, ANVISA and MHRA regulations, as well as best industry practices, complied with the Company’s ethical standards and document control requirements, and established procedures and policies. Increased user understanding through the use of photographs, drawings, diagrams, clip art, and charts.

EDUCATION:

Project Management Professional (PMP in progress)

LearnSmart

Healthcare Compliance Certificate

10/2010

Seton Hall School of Law

Newark, NJ

MS, Technical Communications

5/2001

North Carolina State University

Raleigh, NC

Concentration in Training and Education, Document Design, and Usability Studies BA, Journalism and Mass Communications

12/1995

University of North Carolina at Chapel Hill

Chapel Hill, NC

Concentration in Public Relations, Editing, Graphic Design PROFESSIONAL AFFILIATION:

Society for Technical Communication

Senior Member 1998 to present

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