Associate Director, Quality Assurance Specialist, Oncology

Employer
Merck
Location
Rahway, NJ, US
Posted
April 04 2018
Organization Type
Pharma
Requisition ID: QUA007171

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck 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. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’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. 

 

In partnership with the Quality Assurance Lead (QAL), the Quality Assurance Specialist (QAS) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. The QAS will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to GCP in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

 

The QAS position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/vendors/Country Offices (CO). This role is responsible for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with Merck Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).

 

Primary activities include but are not limited to:

 

  • Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QAmanagement and external relevant stakeholders (e.g. Clinical Operations), and interacts withvarious teams to ensure corrective and preventative actions are taken to bring QA observationsto closure as applicable.
    • Activities may include GCP and PV routine and directed audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, third party collaborations and due diligence activities.
  • Will represent QA as single point of contact and provides QA guidance for studies in a certain TA or in certain countries.
  • Serves as member of project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls.
  • Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.
  • Contributes to the QA strategy and support s QA goals for the aligned studies/countries in a given TA/Region.
  • Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QA assessments and to support the implementation of associated risk mitigation strategies.
  • In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
  • In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements).
  • Be able to analyze and leverage quality indicators and data to identify potential trends and risks, and perform root cause analyses to enable principles of knowledge based auditing within respective TA and/or region.
  • Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions).
Qualifications

Education:

  • BS/BA degree in relevant area with significant experience in field and experience in the pharmaceutical industry including experience conducting a broad range of audits.
Required:

  • Clinical/Regulatory Expertise: Broad and in-depth knowledge of the drug development process, GCP/PV guidelines, and applicable regulations is essential.
  • Business Acumen/Attention to Detail: Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
  • Applied Therapeutic Area knowledge: Familiarity with existing company systems, policies and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct, including all projects/premier products is desirable.
  • Autonomy : Demonstrated ability to work independently
  • Logic and analytical skills: Uses rigorous logic and methods to solve difficult problems with effective solutions.
  • Communications: Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.
  • Leadership: Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.
  • Creative Thinking: Strong ability to operationalize ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.
  • Teamwork: Strong interpersonal skills with the ability to work effectively in teams.
  • Influencing: Ability to influence and negotiate with key stakeholders.
  • Decision Making: Demonstrates good judgment and decision making.
  • Time Management: Ability to multi-task and manage time efficiently and effectively.
  • Cultural Agility: Demonstrates ability to work in a culturally diverse environment.
 

Your role at Merck 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 Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. 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 Merck 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 Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Quality Assurance
Other Locations:
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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