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Associate Director, Quality Assurance (GCP) Job

Date: Nov 14, 2017

Location: London, ENG, GB

Company: MSD

Requisition ID: RES001980

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. MRL 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.


In partnership with the Quality Assurance Lead (QAL), the Associate Director Quality Assurance (AD QA) will support the implementation and management of the Quality assurance strategy across multiple studies, and/or countries. The AD QA 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 AD QA 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) oversight, and for assuring the compliance of studies with MSD Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).

Organization Relationships:



  • Reports, as applicable, to Quality Assurance Therapeutic Area Head or Quality Assurance Lead.

  • Works closely with other QA functions in matrix-management principles.

  • Partners with other QA functions to assure consistent professional and appropriate QA support across project and audit needs.

  • Internal Interface: Works with all relevant QA contacts and other internal local and global MRL staff (GCTO, GRACS, Translational medicine) and other contacts including GHH Medical Affairs, Compliance, Regulatory, Legal and others.

  • External Interface: Works with external contacts including worldwide regulatory agencies as applicable to inspection activities.

Primary Duties and Responsibilities



  • Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.

  • Activities may include GCP 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 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 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 aligned studies, including assessment of potential root causes and remediation (corrective and preventative actions)

  • Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.

  • Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.

  • Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.

  • Provide inspection management support as appropriate.

  • Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as MSD policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.

  • Acts as a strong technical resource and is called upon to resolve GCP issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.

  • Promotes standardization of auditing approach within QA.

  • Routinely suggests new audit techniques/aids in areas of technical expertise

  • Design and actively participate in special assignments on various project teams and work streams as determined by QA management.

  • Provides training and mentorship to less experienced members of QA staff.

  • Requires approximately 30-50% time for conducting audits (including travel) and attending QA meetings.

  • Ensures the work climate/culture within QA, exemplifies the MSD Leadership behaviors.
Qualifications

5-7 years of relevant pharmaceutical experience (i.e., drug development, clinical and/or non- clinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance) including at least 3-5+ years previous clinical Quality Assurance experience conducting a broad range of audits.


Essential Competencies-Technical



  • 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.

Essential Competencies- Behavioural



  • 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. Consistently takes a tactful approach to global thinking and cultural sensitivity. Demonstrates a mutual respect for differences

Other Competencies



  • Logic and analytical skills- Uses rigorous logic and methods to solve difficult problems with effective solutions. Probes all sources for answers; can identify hidden problems. Is excellent at analysis. 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.

  • Nonclinical Expertise (Preferred) - Broad knowledge of the drug development process, GLP guidelines, and applicable regulations is preferred.


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.


 


 


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Job: Research and Development Compliance
Other Locations:
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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