Director, Quality Assurance Pharmacovigilance, London, U.K. Job

Date: Dec 28, 2018

Location: London, ENG, GB

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Requisition ID: QUA007472

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.



MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our research division is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Quality Assurance Pharmacovigilance (QA PV) Director is accountable for ensuring implementation and management of the Quality assurance strategy relating to the MSD pharmacovigilance system across
Headquarters (HQ) and affiliate organizations.

The person in this role reports to the QA PV Head with the following scope:

• utilizes audit and inspection intelligence and risk mitigation plans to assure the appropriateness and effectiveness of implementation and operation of the MSD pharmacovigilance system ensuring that it is compliant with global legal PV requirements
• prevents harm from adverse reactions contributing to the protection of patients’ and public health and
• promotes safe and effective use of MSD’s medicinal products. This is accomplished through close partnership within QA, the Global Clinical Safety and Pharmacovigilance organization, GRACS Quality & Compliance, and across our research functions.
• ensures quality principles are considered throughout the product life cycle, and that quality metrics
• (including audit data) are utilized to inform the business of the state of quality of the MSD Pharmacovigilance system.
• perform risk assessments to identify audit targets, conduct audits, develop and maintain audit tools, and peer-review audit reports and other audit-related documentation.
• ensure quality standards are applied consistently, while allowing for flexible strategies to address the business needs.
• the QA Lead will conduct timely and efficient internal communication of resource and data quality matters to Senior Management as appropriate.
• responsible for managing people and talent management development, including performance management.

Organization Relationships:

• Partners with other QA Functional Leads to assure consistent professional and appropriate QA
• support across programs and regions.
• Internal Interface: Works with all relevant QA contacts and other internal local and global
• Colleagues from our research organisation (Global Regulatory Aaffairs Clinical Safety, Global Clinical Trials Organisation) and other contacts including Global Human Health Medical Affairs, Compliance,
• Regulatory, Legal and others.
• External Interface: Works with external contacts including worldwide regulatory agencies
• as applicable to inspection activities and other external contacts at third party organizations engaged in
• relationships with Headquarters and MSD regarding PV.
• Resources Managed (budget and FTEs):
• Will manage a team of 2-4 QA Specialists, including direct and matrix reports, in addition
• to contracted resources (as applicable).

Primary responsibilities:

• Represents QA as a point of contact in relation to PV.
• Accountable for providing and communicating Pharmacovigilance, Good Clinical Practice, and
• QA expertise, leadership and strategic guidance to relevant stakeholders at global and local levels,
• including pharmacovigilance, regulatory, clinical and Global Human Health, as appropriate, to promote continuous quality improvement and effective quality controls.
• Contributes to the development and maintenance of the QA strategy and accountable for its implementation to support goals of the QA function.
• Actively contributes to quality management oversight, in the development and implementation of risk assessments and quality oversight initiatives (quality plan, quality agreements etc.)
• Maintain robust audit and quality oversight plans for PV.
• Works closely with the applicable global and local pharmaocovigilance organizations and the Global Regulatory Affairs Clinical Safety Quality & Compliance organization to understand customer needs in order to develop, refine and adjust QA strategies and implementation plans.
• In alignment with risk assessments identifies audit targets for scheduling and resource allocation, as appropriate.
• Prioritizes and proactively manages applicable audit schedule, to deliver global audit priorities, modifying as appropriate, to meet the changing business needs.
• Monitors and reviews the audit activities, ensures consistency in approach and reporting, and tracking deliverables against the audit schedule.
• Conducts a range of GxP audits, including complex and for-cause audits, in accordance with QA risk-based processes.
• Identifies areas of greatest risk through intelligence gathering.
• Proactively identify, analyze and leverage quality indicators and data to identify and monitor potential risks and trends with a view to:
- completing risk-based QA assessments
- performing root cause analyses
- identifying opportunities for quality improvements (within both customer areas and QA)
- influencing the implementation of robust mitigation strategies
- implementing principles of knowledge-based auditing
• Work with applicable stakeholders to review the effectiveness of actions to improve pharmacovigilance systems and processes.
• Ensures rapid communication of QA issues including critical audit findings, potential misconduct or issues of significant deviation within PV systems/ processes/ project to appropriate leaders and colleagues
• Is responsible for ensuring delivery of high quality and timely information to appropriate levels of management
• Actively participate in Significant Quality Issue management, including assessment of potential root causes and remediation (corrective and preventative actions).
• Maintains an independent and non-biased role in working with customer area.
• Interfaces with internal QA functions to ensure appropriate quality oversight of interfacing areas, systems and third parties.
• Provides day-to-day support to QA PV functional line.
• Provides guidance and collaborates with QA Specialists, as appropriate, to assure adequate audit focus and timely knowledge transfer.
• Provides training and mentorship to less experience members of QA staff.
• Develops and enhances QA procedures, guidance documents and audit tools to ensure QA
consistency globally.
• Possesses high level of pharmacovigilance expertise and continually enhances knowledge.
• Responsible for practical knowledge of current and emerging global guidelines and regulations,
relevant regulatory approaches and actions, and industry initiatives to develop and advance QA
strategies.
• Provide inspection management support as appropriate.
• Engages in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues.
• Ensures the work climate/culture within QA, exemplifies the MSD Leadership behaviors.
• Requires approximately 20-30% time for conducting audits (including travel) and attending QA
meetings.

People Management (as applicable)

• Resources the operational needs of QA using appropriately qualified/skilled QA Specialists,
• demonstrating optimal skill utilization across a matrix organization.
• Determines colleague skills and drives the development of the global integrated talent pool in
• alignment with the QA strategy.
• Responsible for staff talent development, career development and performance management
• Provides direct, constructive and actionable feedback to direct reports and staff within line
• Prepares direct reports to assume new or increased responsibilities by creating meaningful
• assignments.
• Ensure staff understand resource deployment models and are capable of working effectively in a
• matrix organization to support audit and other QA activities across the QA functional lines.

Qualifications

Qualifications:
Education/Experience:

• BS/BA degree in relevant area is required. Advanced academic qualification/degree is preferred;
equivalent relevant professional experience will be considered.
• A minimum of 10 years QA experience or relevant experience in pharmacovigilance, clinical
quality management, biomedical science, clinical development, or regulatory strategy.
• A minimum of 5 years people leadership experience, i.e. project teams, direct reports, etc. with
proven accountability, and demonstrated excellent interpersonal, communication, negotiation,
influencing, and problem-solving capabilities
• Applied pharmacovigilance experience

Skills :
• Analytical skills
• Communication
• Project Management
• Line Management/Supervision
• Creative Thinking
• Decision Making
• Understanding Customer Needs
• Influencing/ Negotiations / Conflict management and resolution
• Change Management
• Working in a Matrix
• Network and Alliance Building/Peer Relationships


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

MSD is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Quality Assurance
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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