Quality Assurance Manager

3 months ago

Leeds, United Kingdom MAC Clinical Research Full time

MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.


We are seeking to appoint a QA Manager to join our friendly team and make a positive impact in a growing and progressive CRO. This is a fantastic opportunity to join an experienced QA team in an inclusive company that put the needs and wellbeing of their people first, and who deliver exceptional service.


The focus of the job is to manage system, study and vendor audits and other QA activities to match customer expectations. You will also be involved with the rest of the QA team in the management of quality issues arising and the general QMS over all MAC’s operations, we’re looking for a strategical thinker that can plan through any given situation.


You will be largely working from home, with periodic visits to predominately UK sites, with opportunities for international travel as the company grows.


KEY SKILLS:

  • At least 5 years’ experience of GCP- focused audits and other QA activities within a CRO, with some knowledge of other GXPs.
  • Experience and regulatory expertise of industry quality systems/standards, including awareness and understanding of the MHRA Phase 1 accreditation scheme
  • The ability to design, implement, report and follow-up QA audits and other QA activities within the CRO business.
  • Management and leadership experience.

Other:

  • Ability to perform and train others in QA audits and activities within the CRO business.
  • Ability to understand a CRO and/or SMO QMS
  • An understanding of CSV and related IT infrastructure systems and processes.
  • Ability to communicate and negotiate with internal stakeholders effectively
  • The ability to write clear and concise reports
  • Good attention to detail and organisational ability
  • A logical approach to problem analysis and solutions
  • An ability to grade audit/report findings appropriately and manage their workflow
  • Excellent initiative to be able to work alone and with a team
  • Good skills with MS Office
  • A friendly, approachable and helpful disposition

RESPONSIBILITIES:

  • Performing and management of study, system, vendor and other types of audits.
  • Design and implementation of QA SOPs, in conjunction with the QA team.
  • Management of audit and other QA documentation and follow-up of findings
  • Liaising with Sponsors and other staff as necessary, to ensure efficiency and customer satisfaction
  • Keeping updated with the latest regulations and guidelines relevant to the role
  • Management of quality issues arising
  • Management of any applicable risk assessments
  • Assisting the rest of the QA team in study/system/vendor audits, or any other QA responsibilities, as required
  • Hosting or assisting with external sponsor/regulator audits as required
  • Proactive in oversight and development of the QMS
  • Compliance with MAC health and Safety policy
  • Compliance with MAC policy on equality and diversity
  • To maintain any professional qualifications required for the role, including continuous personal development.
  • To work according to MAC SOPs, guidelines and policies
  • To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business-related data.
  • To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure the job role is efficiently carried out
  • To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers

PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS:

Periodic UK travel to investigator sites and meetings, with opportunity to travel to international sites as the business grows. Must be confident driver with full license.

BENEFITS:

  • Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
  • Health Insurance
  • Free onsite parking
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service)
  • Your birthday off work

MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.

Please email maccareers@macplc.com should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.

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