Quality and Compliance Manager/Consultant
MAIN PURPOSE OF ROLE:
This role is responsible for providing consultancy support to Arriello Clients across key technical areas including GxP Compliance, GxP Audits, Quality Management Systems, Quality Risk Management, Quality Control and Quality Assurance. The desired candidate will have previous experience with development and implementation of Quality and Compliance solutions across diverse technical areas and across several different product types. Experience with new facility start up, CQV, GDP and/or sterility assurance would be advantageous.
This role is involved in the development and promotion of Quality and Compliance services to existing and potential clients across the life sciences industry.
Reporting to the VP, this role supports the definition and execution of the internal Arriello Quality and Compliance consultancy strategy and leads service activities within the Quality and Compliance department and across the Arriello technical teams.
What will be your key responsibilities:
ROLE DESCRIPTION:
General
- The Quality and Compliance Manager/Consultant works cross-functionally and in collaboration with key internal stakeholders such as Business Development, Marketing, Pricing and Proposals, Pharmacovigilance, Regulatory Affairs, HR, legal and finance to support the Arriello business strategy.
- Operates as a Subject Matter Expert (SME) in key Quality and Compliance service areas to provide strategic and operational support to Arriello clients.
- Supports service delivery innovation through development of new ways of working or implementation of technology.
- Develops, maintains, and improves the Quality and Compliance department systems and procedures.
- Attendance at and support of, industry events such as conferences and Client meetings for the development of new Quality and Compliance opportunities and growth of the project pipeline.
- Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication.
People Management
- Manage the performance of project resources in the Quality and Compliance team through performance of regular performance evaluation with the Quality and Compliance team members.
- Support the Quality and Compliance team members in their career development through coaching, mentoring, provision of opportunities to increase their expertise and by providing feedback to support this development.
Service Delivery
- Provide technical support to the commercial teams in the scoping of opportunities, identification of solutions based on the Client’s needs, development of project budgets and assembly of project teams with the appropriate expertise based on the project requirements.
- Provide solutions for complex Quality and Compliance issues to support Client goals and requirements.
- Provide technical leadership of assigned Client projects ensuring that technical deliverables are achieved, and client satisfaction is maximised.
- Provide oversight of PM activities to ensure all projects are managed according to agreed procedures, timelines and budgets, relevant hours are billed, and pricing agreements are maintained.
- Collaborate with the VP of Regulatory Affairs, Quality and Compliance in the definition and execution of the commercial and service delivery strategy for the Quality and Compliance department.
- Ensure the standards of quality in client project delivery are upheld and in compliance with ISO9001:2015 accreditation.
- Liaise with international regulatory agencies as required.
- Provision of peer review of all documents prior to submission or transfer to authorities/clients to ensure right first time and maintenance of Arriello quality standards.
- Active participation in identification and assessment of changes in legislation that will impact Arriello clients, providing proactive and practical advice for implementation or response to these changes.
Business Development and Marketing
- Collaborate with the Marketing department to ensure content is provided in support of the Arriello commercial strategy throughout the calendar year and in alignment with the defined Quality and Compliance services offered to Clients.
- Recognize upselling and cross selling opportunities during the delivery of Client’s projects.
- Demonstrate business development and presentation capabilities during bid defence, client meetings and presentations.
- Support with the development of the Quality and Compliance project pipeline.
What experience should you have:
- Minimum BSc. in a scientific discipline or equivalent.
- Eligibility to act as a Qualified Person under EU directives 2001/83/EC, 2001/82/EC, 2001/20/EC and Regulation 536/2014 would be desirable but not essential.
- Experience operating as an RP in compliance with GDP would be desirable but not essential.
- +8 years’ experience in Quality and Compliance and excellent knowledge of regulatory legislation and guidance across several territories including US and EU and in particular.
- Expert knowledge in the development of Quality and Compliance solutions across different product types and across GxPs.
- Experience with innovative biotechnology medicinal products including biologics, ATMPs/CGTs.
- Competent in assessment and provision of innovative solutions for complex GxP issues.
- Excellent project management skills.
- Analytical skills; strong attention to detail
- Strategic planning skills.
- Capable of managing multiple projects and complex timelines.
- Ability to work independently and on own initiative.
- Creates a working environment that supports diversity and inclusion while working in a multi-cultural environment.
- Client focused.
- Leads by example.
What do you get in return:
- Remote working (Use of our offices in various locations, co-sharing work space or remote options available)
- 5 weeks holiday plus national holidays in your given location
- 3 personal days
- Flexible benefits, based on location
- Home office stipend
- Annual bonus program
- Other employee Bonuses (spot bonuses and employee nominated bonuses)
