Job Description
The Associate Director, Pharmacovigilance (PV) Quality Assurance (QA) is accountable for the planning and execution of assigned PV QA audit activities across our organization, the Research & Development Division Headquarters (HQ), Country Operations (CO), business partners and vendors. In this role, the Associate Director, PV QA is responsible for the conduct of complex PV audits and activities. This includes preparing for and conducting assigned PV QA audits of various complexity levels and generating audit reports that clearly communicate complex observations, as applicable. In addition, responsibility for communicating results to the relevant QA management and external stakeholders and interacting with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable is key for ensuring that the PV system is in compliance with our Company's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g., US FDA, EU Directives, ICH, and National regulations).
The Associate Director, PV QA is an independent contributor and team member who provides key support for successful execution of our Research & Development Division PV QA audit program following QA strategic plans and directives to ensure appropriate preparation of PV materials, communication, and reporting of information to advance patient care and promote safe and effective use of our organization's medicinal products and vaccines. This is accomplished through close partnership between PV QA and applicable business organizations. The Associate Director, PV QA may assist the Director, PV QA Lead in utilizing audit and inspection intelligence and risk mitigation plans at the highest complexity levels to assure the appropriateness and effectiveness of implementation and operation of the Research & Development Division PV QA audit program. This position supports quality activities, performs risk assessments to identify audit targets, conducts audits at all complexity levels, develops and maintains audit tools, and peer-reviews audit reports and other audit-related documentation.
The Associate Director, PV QA works as part of a team to assure quality standards are applied consistently, while allowing for flexible strategies to address the business needs. They conduct timely and efficient internal communication of resource and quality matters to the Director, PV QA Lead, as appropriate.
Under the direction of the Director, PV QA Lead, the Associate Director, PV QA is responsible to:
- Represent QA as an initial or assigned point of contact in relation to PV
- Conduct assigned PV routine and directed audits of country offices, vendors, third-party collaborations, systems/processes and due diligence activities
- Ensures rapid communication of PV QA issues including critical audit findings, potential misconduct or issues of significant deviation within PV systems/ processes/ project to appropriate leaders and colleagues
- Serve as member of assigned project teams with participation in the applicable forums, providing PV compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls
- Interface with relevant stakeholders, as appropriate to provide Good Pharmacovigilance and QA support and input
- In collaboration with the PV Lead, contribute to the development of PV risk assessments and PV QA audit program initiatives
- Support stakeholders in the assessment of potential root causes and remediation (corrective and preventative actions)
- Participate in the development/enhancement of PV QA procedures, guidance documents, and audit tools to ensure PV QA consistency globally
- Develop and deliver awareness sessions with minimal supervision on various PV QA topics internally and externally
- Act as a strong technical resource and is called upon to resolve PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), PV regulations and guidelines as well as local regulations
- Promotes standardization of PV auditing approaches
- Serve as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge
- Assist with the preparation or review of relevant SOPs or policies relevant to Research & Development Division PV QA or partnering Research & Development Division organizations
- Maintain an independent and non-biased role in working with customer area
- Interface with internal QA functions to ensure appropriate quality oversight of interfacing areas, systems, and third parties
- Provide guidance and collaborate with other PV QA auditors, as appropriate, to assure adequate audit focus and timely knowledge transfer
Qualifications & Skills:
- Bachelor's Degree or equivalent in life sciences.
- A minimum of 8 years QA experience, preferably related to pharmacovigilance, or relevant experience in pharmacovigilance coupled with auditing experience
- Demonstrated in-depth knowledge of global health authority pharmacovigilance requirements, guidance, and expectations. This should include FDA, EMA, and MHRA, at a minimum.
- Demonstrated knowledge of global health authority GCP and GMP requirements and guidance (ICH) in areas that intersect with pharmacovigilance.
- Demonstrated understanding of Quality Systems concepts and processes and how auditing and other QA activities support the growth and maturity of the system.
- Proven ability to interact with a variety of disciplines to execute and optimize processes
Personal competencies:
- Pharmacovigilance: Excellent knowledge of pharmacovigilance, including practical application of applicable global regulations and guidelines is essential. Awareness of industry trends and hot topics relating to pharmacovigilance.
- Quality Assurance Technical Expertise: Strong quality orientation and excellent knowledge of quality principles. Demonstrated knowledge of principles of quality assurance. Strong auditing skills.
- Logic and Analytical Skills: Demonstrated use of rigorous logic and analytical methods to solve difficult problems and identify effective solutions. Probes all sources for answers; can identify hidden problems, common themes, and causal links. Goes beyond the obvious and seeks novel approaches to complex situations.
- Communications: Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats. Articulates key issues clearly and concisely. Demonstrates effective oral and written communication skills. Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Project Management: Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines. Manages and resolves conflicting priorities and is accountable to deliver on commitments.
- Management/Supervision: Able to mentor less experienced staff to represent the full knowledge and experience base of QA in their stakeholder interactions.
- Leadership: Act independently to make key timely decisions with limited oversight by management.
- Creative Thinking: Ability to operationalize ideas proposed. Open to new ideas or ways of working. Encourages and influences creative thinking.
- Understanding Customer Needs: Ability to influence and negotiate with internal and external stakeholders to promote positive interactions and successful relationships. Take action to persuade. Proactive management of potential/actual conflict scenarios, with effective use of emotional intelligence.
- Influencing/ Negotiations/ Conflict management and resolution: Ability to work in a culturally diverse environment. Consistently takes a tactful approach to global thinking and cultural sensitivity. Demonstrates a mutual respect for differences.
- Change Management: Effectively implements procedures to support effective change management. Copes with ambiguity in the business environment and able to reach decisions and solutions. Demonstrates resilience to the demands and changing needs of the business.
- Working in a Matrix: Accepts and champions working in a matrix model within and outside of QA organization
- Network and Alliance Building/Peer Relationships: Interacts with a variety of disciplines to establish policy and optimize processes. Demonstrated ability to work with or lead a team in a matrix structure.
- Strategic Thinking: Effectively applies skills to drive or participate in change efforts to enhance processes within Research & Development Division QA or across areas within Research & Development Division that improve quality and /or add value to the business.
- Project Management: Demonstrates advanced ability to organize work efforts and utilize resources to deliver or support work products in accordance with timelines and appropriate regulations.
- Decision Making: Effectively applies skills to utilize knowledge, networks and data to support rapid decision making with support of Research & Development Division QA management.
- Business Operations/Knowledge of Field: Effectively applies knowledge of regulations and business trends and applies this knowledge to optimize daily activities and collaborates with Research & Development Division QA management to make appropriate decisions that improves the quality of business and functional area outputs.
- Readiness to travel locally around 30% of the time.
- Ability to work efficiently in a remote and virtual environment.
#EBRG
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are ...
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$118,640.00 - $186,800.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Flex Time, Remote Work, Work Week
Shift:
Valid Driving License:
No
Hazardous Material(s):
Requisition ID: R227067