We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity! Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Associate Director Quality Project
This role is a combination of an Associate Director expert and an Associate Director team manager, as you will have people management as well as operational activities in scope.
*** This resource will be attending the Paris office on a weekly basis, hence the right candidate should be based in Paris or surroundings ***
- Provide a full range of consulting services (expert insight, guidance and/or operational support, writing and training)
- Provide regulatory strategic advice for the life cycle management of pharmaceutical products for France
- Interaction with Health Authorities
- Manage/support the local process for “exploitant” authorization and opening
- Participate into self-inspection or authorities inspection
- Contribute to bi-annual quality reviews and annual quality management review
- Review/Approve deviations, corrective / preventive actions, change controls, and quality action plans
- Contribute to the management of the quality system documentation
- Deliver internal trainings related to quality and regulatory topics
- Reviews quality indicators and improvement plans
- Manage the local launch activities at French level and early access program (e.g., AAP/AAC)
- Approval of Packaging artworks
- Reviews and provides advice in the preparation of MITM assessment and shortage management plan
- Review/write quality and technical agreement (QTA)
- Review Partner qualification assessments
- Review the follow-up of third parties providers
- Prepare/participate to client audits
- Manage the process of product complaints process and batch follow-up
- Manage, supervise, support, and develop a group of project managers/specialists and consultants providing strategic advice and/or operational services to clients
- Implement and lead effective supervision, support, mentoring, and coaching
- CNOP registration is a must
- Minimum 8 years of previous experience in pharmaceutical/biotechnical companies and/or regulatory authorities
- Regulatory experience gained within a fast-paced environment
- Ability to lead a team of permanent consultants and contractors by delegating and providing regular support and guidance in a professional manner
- Demonstrable ability to coach, train and mentor teams
- Excellent verbal communication skills across multiple levels of an organization
- Ability to represent the functional department at senior level meetings
- Established relationships and proven negotiation skills with management, colleagues and/or regulators
- Decisive and proactive, with “small company” hands-on, can-do style and attitude
- Strong interpersonal skills & leadership
- Ability to work on multi-projects in a multi-cultural and matrix environment
- Native French and full professional proficiency in English are a must
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us.
Agencies only by prior agreement for the specific job opportunity.