Director of Quality

OPEN HealthMarlow, Buckinghamshire

About OPEN Health

OPEN Health is a family of expert practices, working in partnership to drive positive change in healthcare communications and market access.

Founded in 2011, and previously a group of eight separately branded businesses, OPEN Health has now re-structured into three specialist practices, all operating under the OPEN Health brand.

• OPEN Health Medical Communications (previously Succinct and now includes US-based Peloton Advantage)

• OPEN Health Patient & Brand Communications (previously The EarthWorks, Reynolds-MacKenzie and LEC)

• OPEN VIE: Value, Informatics, Evidence (previously pH Associates, Harvey Walsh and OPEN Access Consulting)

Collaboration and connectivity is a founding philosophy and will continue to be a key driver for OPEN Health, providing value for our clients and also offering an environment in which our employees can continue to thrive.

With offices in the UK and US, and over 500 employees, OPEN Health works with 90% of the world’s top 40 pharmaceutical companies across a broad client base, including biotechnology and medical device companies. Our therapeutic range is extensive, with particular strength and focus on oncology, rare diseases and specialist medicines.

About OPEN Health Centre

Assisting performance through supporting our practices

OPEN Health Centre provides all the support functions required to enable and enhance the running of our high-performing practices, including:

• Business Development and Marketing

• Facilities Management and Administration

• Finance

• HR and Talent Acquisition

• IT and Operations

• Legal and Compliance

You will love this role if you:

• Thrive on challenges and enjoy implementing change, with a particular focus on transforming business quality management systems

• Enjoy working among likeminded professionals in a fast-paced and friendly environment

• Pay attention to the details but always in the context of the strategic direction and requirements of the business

• Enjoy ensuring processes comply with regulated requirements

You will be a success if you have:

  • Good experience of implementing Quality Management Systems (QMS) in different environments and cultures
  • A sound understanding of the principles of QMS in Pharma (non-interventional and low-interventional studies) as well as medical research regulation including a thorough knowledge of GCP, 21 CFR and FDA and ABPI and BHBIA requirements
  • Operated at a senior management level
  • An approachable style and a can-do attitude
  • A good attention to detail
  • The ability to manage multiple priorities in a changing environment

As part of the OPEN Health Centre Legal, Compliance and Quality team, you will be responsible for the following activities:

  • Lead the regulated quality approach across OPEN VIE and other regulated practice areas
  • Enhance current systems and implement required changes to working practices to ensure QMS processes are part of organisational DNA
  • Ensure the control, coordination, planning and continuous improvement of systems and processes to ensure projects follow required Good Clinical Practice (GCP) and QMS rigour
  • Develop and maintain the appropriate Quality Plan and Manual
  • Maintain and manage required Standard Operating Procedures (SOPs)
  • Support the Information Security Officer (ISO) for OPEN Health in quality best practices and approaches including the systems development lifecycle (SDLC)
  • Monitor and support the quality processes of individual practices that work to accredited standards (e.g. ISO compliance)
  • Maintain existing accreditations as well as lead extension of new accreditations if appropriate
  • Centrally sponsor and lead QMS and input into strategy development
  • Be responsible for leading and/or supporting the external and internal auditing activities and plans (limited travel)
  • Work collaboratively with colleagues to achieve results
  • Support the healthcare data collection teams in reviewing study methodologies

What you will bring:

  • Minimum of 10 years’ relevant experience of working in a senior quality role in healthcare research, Pharma, agency or a clinical research organisation
  • Experience of setting up and running QMS in the Pharma environment
  • Graduate or relevant healthcare qualification
  • Strong leadership skills and experience of creating change
  • Excellent communication and relationship building skills (verbal and written)
  • A flexible attitude, self-motivated and an ability to work independently
  • Persuasive, positive and assertive attributes
  • Systematic, logical, thorough and precise thinking and execution
  • Sound IT skills - knowledge of Word, Excel and PowerPoint as well as QMS

What we offer:

At OPEN Health, we are entirely dependent upon our people. They are the basis of every contract we win, every service we provide and every project we deliver. As a result, we are always on the lookout for the brightest, most enthusiastic, creative and ambitious individuals to join our teams in the UK and USA. We work hard to create friendly and collaborative workplaces, to provide fascinating professional challenges and amazing opportunities.

We have an extensive benefits package that includes:

  • •A total of 28 days holidays – 25 days plus an additional 3 days at our Christmas shutdown plus your birthday off
  • Flexible start and finish times around core office hours
  • 4 pm Friday finish
  • A training platform that provides access to self-paced and face-to-face learning and development
  • Group Income Protection
  • Private Medical Insurance
  • Employee Assistance Programme
  • Life Assurance
  • Enhanced parental leave
  • Casual dress code
  • Active CSR community supporting a range of worthwhile causes

If we sound like the sort of business environment in which you would thrive, then we would love to hear from you.

Apply directly via our website: https://www.openhealthgroup.com or send the Talent Team an email: talentteam@openhealthgroup.com


Location

The Georgian market town of Marlow sits on the River Thames, among meadows and woodlands. The town centre features boutique shops, cafes and bistros and Michelin-starred restaurants all within a few minutes’ walk of the OPEN Health offices.



About OPEN Health

OPEN Health is a family of expert practices, working in partnership to drive positive change in healthcare communications & market access.

Currently, we are a group of around 500 people, operating across a wide range of disciplines. We work with almost all of the world’s top 40 pharmaceutical companies, as well as with many device, diagnostic and healthcare delivery organisations, from small start-ups to major multinationals at a UK, regional and global level.

Through our ‘no walls’ approach to collaboration, OPEN Health can bring together the most appropriate team to develop and deliver the best possible solutions for our clients.

Apply for this position

If you're interested in this position, please click the link below to apply. If you have any questions, please email us at talentteam@openhealthgroup.com, or call the Talent Team on 01628 481112.

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