Senior Director Quality Assurance

Senior Director Quality Assurance

Clinipace

London, United Kingdom

Job Overview:

The Senior Director of Quality Assurance is responsible for implementing, in cooperation and agreement with the Global Quality Services team, quality assurance and quality control systems with written SOPs to ensure that clinical trials are conducted, and data are generated, documented, and reported in compliance with the protocol, GCP and the applicable regulatory requirements. The position may be assigned responsibility for line management and oversight of Quality Assurance Auditor personnel and or may be assigned additional specialty auditing and compliance oversight responsibilities. This may include areas of compliance expertise in Pharmacovigilance, Good Distribution/GMP expertise in a region, oversight of centralized Quality Event and CAPA management, Key Client/Quality Agreement Oversight, oversight of the QMS, and or Vendor Management oversight responsibilities. The focus of the position is to develop, perform and manage, in cooperation with the Global Quality Services team, all Quality Assurance-related activities such as internal GCP auditing, conduct of contracted GCP audits, GCP/GXP vendor compliance, Quality Event, and CAPA management and contributing to the development of an effective Quality Management System.

Job Duties and Responsibilities:

  • Supervises and coordinates Quality Assurance (QA) activities, supports development of the company's Quality Management System (QMS);
  • Responsible for providing direction, oversight of QA Auditor staff as it pertains to assigned audit responsibilities. This includes determination, prioritization, and assignment of GCP/GXP audits to be conducted in collaboration with the Head of QA and QA Auditor team member(s);
  • Participates in and supports organizational reporting for the meetings of the Quality Assurance Unit and the Quarterly Quality Assurance Committee;
  • Supports coordination of the SOP life cycle (writing, revision, review, release, training, etc.), making recommendations, and initiating process development and revision to mitigate risk;
  • Supports, hosts, and contributes to preparation and conduct of inspections performed by regulatory agencies, audits performed by customers, and is present or organizes presence of qualified personnel during inspections/sponsor audits as required. Coordinates the processing of inspection/audit findings and is responsible for the follow-up and closeout of these findings as assigned;
  • Manages the Continuous Quality Improvement cycle as per Quality Manual, keeping the SVP Global Quality Services informed of significant or critical issues on a timely basis, and works with regional QA management and colleagues as needed to address any QA-relevant issue detected together with suggestions of actions to take;
  • Plans and performs or supervises performance of internal system audits as assigned and project and site-specific audits according to the audit plan agreed with the management. Writes internal audit reports and coordinates the processing and follow-up of internal audit findings;
  • Performs peer review of audit reports and reviews and approves Quality Events and CAPAs as applicable;
  • Supports writing and implementation of project-specific quality management plans, as necessary and agreed upon;
  • Plans, performs, and reports external GCP/GXP vendor audits as assigned and applicable to expertise required;
  • Identifies areas as needed requiring additional training and looks for opportunities to further advance compliance knowledge, and takes opportunities to share that knowledge internally within the department;
  • Identifies areas of compliance training lacking within the organization and proactively recommends and/or prepares/delivers training to further compliance awareness organizationally and mitigate risk;
  • Coordinates/prepares Quality Agreements as applicable and oversees the compliance to approved Quality Agreements, including preparation and conduct of Quality Agreement meetings and quality metrics as applicable to approved Quality Agreement Plans in place;
  • Performs all duties as assigned, including those related to areas of additional expertise or responsibility for compliance oversight for specialty areas such as Pharmacovigilance and GDP/GMP if applicable.

Supervisory Responsibilities:

Responsibility to supervise, provide work direction, manage and support assigned quality assurance auditor personnel as a line manager or as applicable to assigned audit programs or tasks. Carries out supervisory responsibilities in accordance with the organization's policies and applicable local laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; performance management; addressing complaints and resolving problems.

Job Requirements:

Education

  • BA/BS, preferably with a healthcare or life science degree.

Experience

  • Minimum of 12 years of experience within clinical research;
  • Minimum of 10 years experience as QA Auditor in Quality Assurance with a focus of experience in GCP and site auditing;
  • Experience in hosting or supporting Regulatory Inspections and or Sponsor audits;
  • Minimum of 5-8 years of QA staff line management or similar oversight experience;
  • Evidence of leadership experience in managing, mentoring, and training staff for audit activities, either direct reports or in providing oversight for one or more auditors.

Skills/Competencies

  • Strong written and verbal communication skills, excellent questioning and listening skills with the ability to analyze responses;
  • Strong interpersonal skills; ability to give and receive feedback in a constructive and team-building manner; ability to mentor and develop staff, establishing priorities and obtaining staff commitment and follow thru;
  • Comprehensive knowledge of GCP and relevant regulatory requirements;
  • Maintains current knowledge of applicable regulations and regulatory Guidance documents pertaining to investigational clinical trial conduct;
  • Demonstrates effective Leadership skills;
  • Demonstrated ability to set priorities and keep commitments;
  • Able to exercise judgment within defined procedures and practices and to determine appropriate action independently;
  • Superior problem-solving skills;
  • Able to issue instructions and make decisions;
  • Reliable and trustworthy;
  • Self-motivated and continually strives to keep up to date with all applicable quality and compliance regulations and guidelines impacting practice;
  • Evidence of ability to independently oversee areas of compliance responsibilities that may either reflect specialty compliance competencies or areas of increased responsibility or management oversight as delegated by the SVP, Global Quality Services.

Capabilities

  • Technologically skilled in quickly learning new systems and leveraging data and systems available in the performance of assigned tasks;
  • Windows, Word, Excel, PowerPoint, MS Teams, WebEx, eTMF, EDC, and CTMS systems;
  • Ability to work remotely;
  • Up to 30% travel as needed;
  • Must have a credit card that can be used for travel expenses.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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