Overview of the role
Venn Life Sciences, part of Open Orphan plc, is an Integrated Drug Development Partner offering a unique combination of pre-clinical and CMC drug development expertise, clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients.
?Our vision? is to play a pivotal role in the development of new products enabling disease prevention and treatment We do this by creating an environment that generates opportunities for employees to stretch their potential and fully exercise their talents thereby consistently providing outstanding service to our clients. We nurture an environment of respect, pro activity, teamwork and above all keep the patient at the heart of what we do.
We are currently looking for a Sr Manager / Head of QA to manage the Venn Life Sciences QA team and to ensure the robustness and effectiveness of the organization?s Quality Management System (QMS). The job also includes the execution of contracted QA services, such as audits on Venn projects or consultancy projects, as assigned.
This job offers a combination between line management responsibilities and hands-on QA work. You will also work closely with the other QA heads within the broader Open Orphan Group.
This function can be based in Breda (The Netherlands) or Paris (France) (with travel to the other site). Home-based can also be considered for the right candidate, with frequent travel to both sites.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
Main Responsibilities & duties
Line management
- Act as QA lead for Venn Life Sciences
- Line manager of the Venn Life Sciences QA team
Quality Initiatives:
- Establishing a clearly defined QMS that is robust and effective in ensuring regulatory compliance.
- In collaboration with assigned operations departments, support the development of written procedures (SOPs) that ensure compliance with applicable regulatory requirements and industry standards.
- Ensure SOPs are properly understood, carried out and evaluated by working closely together with functional departments.
- Investigate and report on deviations. Ensure effective root cause analysis is performed and adequate CAPA plans are defined and implemented in a timely manner.
- Identify process improvement opportunities and foster a culture of quality.
- Lead internal quality focused meetings.
- Attend meetings and conferences as required.
Advice & Expertise:
- Develop training materials and/or deliver training related to quality, as assigned, and in collaboration with the Training department.
- Provide guidance and support to project teams on the pragmatic interpretation of GxP, Procedural Documents (SOPs), quality and regulatory requirements.
- Help develop and maintain quality management related metrics to help the company understand how it is performing with respect to quality.
Auditing:
- Effectively manage the relevant part of the internal QA audit program in accordance with applicable procedures and utilizing a risk-based methodology.
- Plan and conduct programmed and contracted audits according to applicable procedures and/or client expectations.
Consultancy:
- Can be assigned as QA consultant on client QA projects depending on required technical expertise and experience.
- Can lead consultancy projects when a team of Venn consultants is assigned on a client project.
- Ensure the proper execution of the contracted consultancy services in accordance with client expectations with regard to cost, quality and timelines.
General:
- Guide, coach, supervise and train professionals in the company especially QA Associate and QA Administrator.
- Develop a recognized QA working knowledge in addition to main field of GxP expertise.
- Maintain and build a professional network.
- Stay up to date with current trends, knowledge and developments in area of expertise and proactively identify opportunities to update and increase knowledge and share with others (internally & externally via training, symposia, articles, etc.);
- Completion of additional tasks not specified herein as required by management to ensure successful business operations.
Skills & Experiences
Qualifications & Experience:
- University (or comparable) degree in life sciences such as BSc or MSc.
- Minimum 8 years? international (non-) clinical research experience in a pharmaceutical company, CRO or regulatory body or equivalent combination of education, training and experience.
- Minimum of 4 years? experience in Quality Management, with a particular focus on GCP quality systems and minimum of 2 years? auditing experience in GCP and/or GLP.
- Experience conducting root cause analysis, review of effective CAPA plans and risk management principles.
Skills
- Excellent knowledge and understanding of ICH/GCP and/or OECD GLP requirements (GMP also desirable).
- Excellent interpersonal skills with the ability to work diligently, accurately and under pressure, alone and/or as part of a team.
- Ability to find effective solutions to deal with complex matters (e.g. resolving independently or with support of other (e.g. external parties)
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Excellent influencing, organisational and leadership skills with demonstrated ability to listen, lead and motivate particularly across a multicultural organisation.
- Ability to communicate to clients and identify client needs.
- Demonstrated project management skills.
- Ability to multi-task, with skill in establishing priorities and managing workloads.
- Ability to communicate effectively at different levels within and outside the company.
- Excellent writing and verbal communication skills including fluency in English (additional language skills desirable).
- Ability to be flexible and to adapt and work effectively with a variety of situations or individuals.
- Excellent networking skills to connect to pharmaceutical / biotech companies.
- Proficiency in PC skills (e.g. SharePoint, MS Office and Outlook).
- Flexibility to travel and work at different locations;
How to apply:
Please forward your CV (in English) by email to careers@vennlife.com
We do not require the services of agencies for this role. –
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