Quality Compliance Manager

Found in: Appcast Linkedin GBL C2 - 1 week ago

Rockland, United States EMD Serono, Inc. Full time

Quality Compliance Manager

100% onsite in MA

Pay: $60.00 an hour

Bachelor's degree with a minimum of 3 years in a quality and compliance role (Pharmacovigilance)

Possible contract to hire opportunity


Description

The focus for this position is coordinating, managing, and leading a variety of Pharmacovigilance (PV) quality and compliance activities. This position will report to the Global Patient Safety, US Region Deputy Local Patient Safety Officer (GPS, US LPSO).


Responsibilities

This role will support oversight of GPS, US regional activities from a compliance perspective and drive new and existing quality, oversight, and compliance initiatives in collaboration with GPS, US management. This will be demonstrated by the following job duties.

Process Development & Management

• Ensuring that GPS, US PV systems and activities are adequately covered by policies, guidelines, standard operating procedures and/or related procedures

• Contributing to the development and maintenance of GPS, US PV systems and processes in alignment with US regulatory, compliance, and industry requirements

• Monitoring for changes and new developments in PV requirements, regulations, and global procedures, supporting impact assessments, and implementing solutions to address any gaps

• Supporting GPS, US in the monitoring of changes and new developments in the regulatory PV requirements globally as needed

• Supporting PV systems and activities with user acceptance testing as required

• Reviewing and providing feedback as necessary for compliance quality and monitoring Modules of PSMF and develop PV system report and provide feedback to the leadership team

Quality Issues & CAPA management

• identifying quality and compliance issues impacting GPS, US and managing related activities in Quality Management System including deviation investigation, CAPA implementation, effectiveness review and approval

• Monitoring and trending of quality issues related to GPS, US procedures and presenting on a routine basis, and as require escalating, trends and risks to GPS, US management

Oversight & Compliance Monitoring

• Monitoring and reviewing GPS, US PV systems, procedures, and activities for adherence to US regulatory, compliance, and industry requirements

• Identifying opportunities for quality improvement, efficiency, and industry best practices

• Tracking and trending GPS, US outcome measures and performance reports to evaluate overall effectiveness of existing processes for quality and adherence with US regulatory, compliance, and industry requirements

• Identifying trends and escalating risks to GPS, US management on a routine basis

• Managing and presenting the preparation of PV specific periodic metrics related to Key Performance Indicators, Quality Incident Investigations, CAPAs, audits and inspections outcomes with support from GPS, US managers

• Performing quality reviews of periodic aggregate safety data, ICSRs and other safety documents/information health authority submissions to assure appropriate level of quality and accuracy

• Maintaining documentation to support continuous improvement and inspection readiness for GPS, US

Audits & Inspection Readiness

• Supporting GPS, US and subsidiary activities for audits and inspection readiness planning

• Ensuring the accuracy, completeness, and audit readiness of PV documentation, Metrics, KPIs, and QPIs

• Coordinating and providing ongoing support during inspections and audits (internal/external audits), including pre-audit/inspection requests and during audits/inspections

• Preparing subject matter experts, and their back-ups, to present their functions during audits and aid in creating storyboards

Other

• Supporting PV training activities and compliance for new and existing staff in GPS, US and the subsidiary

• Supporting product safety surveillance, call center support, handling, and regulatory reporting as backup, if needed


Qualifications

• Bachelor's degree with a minimum of 3 years in a quality and compliance role

• A proven track record in pharmacovigilance with several examples of supporting pharmacovigilance compliance monitoring and quality activities

• Knowledge of case processing/case management, data quality review for aggregate reports and RMPs and evaluation/reporting of PV system performance is required

• Direct experience with quality systems, safety systems, and tracking, compiling, and analyzing quality metrics

• Demonstrated ability to apply principles, concepts and industry best practices governing pharmacovigilance in assigned projects and company deliverables

• In depth knowledge of US safety reporting activities, regulations, ICH/GXP guidelines, and pharmaceutical industry compliance practices, understanding of research methods and basic data analysis, GVP, working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally

• Highly organized, problem solving, and outcome oriented

• Demonstrated ability to work independently as well as collaboratively with other team members locally and globally

• Excellent written and verbal communication skills; must be able to communicate effectively regarding safety data, oversight and compliance metrics, and issues related to safety and pharmacovigilance

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