• MAC - FULL TIME

QA MANAGER - VENDOR QUALIFICATION

Closing date for applications: 27 May 2022

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 – Vendor Qualification to join our team and make a positive impact in a growing and progressive CRO. You will be joining a company that put the needs and wellbeing of their people first, who are inclusive and who deliver exceptional service – together.


The Focus of the job is to ensure, as part of the vendor qualification team, that all vendors contracted by MAC are fit for purpose by planning, conducting, reporting and follow-up of vendor qualifications. You will also assist the rest of the QA team in oversight of the QMS, which will include other types of audits.


KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

Key:

  • At least 5 years’ experience of GCP- focused vendor audits within a CRO, with some knowledge of other GXPs.

  • The ability to design, implement, report and follow-up vendor audits for a wide variety of suppliers in the pharmaceutical industry.

  • Management experience.

Other:

  • Ability to train others in vendor qualification

  • Ability to understand a pharmaceutical QMS and associated regulations

  • Excellent interpersonal skills

  • 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

RESPONSIBILITIES (including staff):

  • Management of qualification of all MAC vendors globally

  • Management and training of QA auditors involved in vendor qualification

  • Design and implementation of vendor qualification SOPs, in conjunction with the vendor management team

  • Management of vendor qualification documentation and follow-up of findings

  • Liaising with SMEs, contractors sponsors and the rest of the vendor management team to ensure timely and efficient vendor qualifications

  • Organising completion of incoming vendor qualification questionnaires, as appropriate

  • Keeping updated of 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 audits, or any other QA responsibilities, as required

  • Hosting or assisting with external sponsor/regulator audits, as required

  • Proactively assisting the QA team 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 international qualification visits to global vendors, and to meetings as required. Periodic UK travel to meetings and to assist QA auditing team. Must be a confident driver.


BENEFITS:

  • Competitive salary in keeping with pharmaceutical industry standards and will reflect experience

  • Free onsite parking at MAC office locations

  • Health Insurance

  • 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)

MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve 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 note that if we receive a high volume of applications this date may be brought forwards.


Job Description - QA Manager Vendor Qualification
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Salary: Competitive + Negotiable £ Apply Now



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