Merck Executive Director, Safety, Regulatory and Medical Quality Assurance in North Wales, Pennsylvania
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.
Under the direction of the Head of RESEARCH & DEVELOPMENT QA, the Safety, Regulatory and Medical Quality Assurance Head is responsible globally for the overall Quality Assurance activities, assessments, audits and quality oversight for Safety, Pharmacovigilance, Regulatory, CORE and Medical Affairs activities at The company Headquarters (HQ) and Affiliate Organizations. The Safety, Regulatory and Medical Quality Head will define the overall quality assurance strategy including risk assessments for Safety, Pharmacovigilance, Regulatory, CORE and Medical Affairs activities utilizing stakeholder and subject matter expert feedback, audit and inspection intelligence, industry trends and other relevant data to assure adherence with relevant GxPs, The company policies and procedures, relevant local laws, regulations and best practices. Additionally, the Safety, Regulatory and Medical Quality Assurance Head is responsible for the advancement and continuous improvement of our Quality Assurance processes, procedures and practices with respect to these business functions in support of our quality system. The Head will provide strategic consulting and support to The company HQ and affiliate organizations in support of health authority inspections and responses to inspections. This role is a member of the QA Leadership Team.
Primary activities include but are not limited to:
Represents QA as the single point of contact for Quality Assurance activities and is responsible for understanding unique needs of Safety, Pharmacovigilance, Regulatory, CORE and Medical Affairs HQ and Affiliate organizations
Accountable for the operational RESEARCH & DEVELOPMENT QA strategies Safety, Pharmacovigilance, Regulatory, CORE and Medical Affairs related quality assurance activities and audits including the quality risk assessments, selection of audit targets and associated deliverables for The company and service providers supporting business functions
Leads RESEARCH & DEVELOPMENT QA in the development of functional quality risk mitigation strategies for Safety, Pharmacovigilance, Regulatory, CORE and Medical Affairs related quality issues impacting HQ, affiliates, countries and regions (e.g., labeling, patient support programs)
Ensures Quality Assurance alignment with the RESEARCH & DEVELOPMENT Quality System
Provides health authority inspection consulting and support
Provides due diligence support of vendors as appropriate
Builds and develops a strong team of quality assurance professionals
Serves as an active member of the RESEARCH & DEVELOPMENT QA Leadership Team
Participates in and supports Global Regulatory Affairs and Clinical Safety Compliance Council
Represents Quality Assurance on relevant governance meetings
Maintains current knowledge of regulations, industry quality trends and actively builds and shares quality knowledge internally and externally
Collaborates on the development and implementation of robust strategic sourcing solutions for the RESEARCH & DEVELOPMENT QA organization in partnership with RESEARCH & DEVELOPMENT QA LT
Advises on the RESEARCH & DEVELOPMENT QA vision and strategy and supports the execution of activities furthering the vision and strategy
Advanced academic degree is preferred
Bachelor’s degree or equivalent experience is required
Qualifications and Requirements :
15+ years safety, pharmacovigilance oversight experience or relevant experience in regulatory affairs, quality management, biomedical science, clinical development, or other equivalent experience
5 + years’ experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
Demonstrated leadership capabilities
Demonstrated teaching and coaching capabilities and experience as a manager of people
Proven ability to function autonomously at a senior level in a matrix model and in a team environment
Proven ability to think creatively and to develop and execute strategic plans
Ability to travel at approximately 30%
Demonstrated knowledge of ICH GCP, GPVP, current Outcomes Research and Medical Affairs practices
Understanding of Quality Systems
Ability to solve difficult problems with logical effective solutions
Ability to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats
Ability to mentor less experienced staff
Ability to interact with a variety of disciplines to establish policy and optimize processes
Considers customers, including regulatory agencies, clinical, safety, outcomes and medical affairs colleagues in developing strategies, risk priorities and future direction
Ability to Influence, negotiate with internal and external customers
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
If you need an accommodation for the application process please email us at email@example.com
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
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Number of Openings:
Requisition ID: R24860