Do you have 15 years of experience in Quality and Regulatory Affairs?
Are you looking for an opportunity to develop and implement Quality procedures and technical guidance?
Are you located in Illinois, US, or are you willing to relocate?
Fraser Dove International is collaborating with a growing biologics organisation specialising in developing innovative therapies for patients with neurogenerative diseases. Operating worldwide, they are committed to advancing treatments and saving lives.
Our client is seeking an experienced leader to act as the Subject Matter Expert of all things Quality and prepare for the inspection and commercialisation of products across the US.
Discover more about our Director of Quality opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Director of Quality, you will be measured against the following objectives:
1) Acting as the primary contact for Quality in the US, collaborating with other functions to bring more awareness of Quality across the business.
2) Preparing for inspections and helping in the commercialisation of products across the US.
3) Building your own Quality function within the US.
What you will do:
As the Director of Quality, your duties and responsibilities will include:
- Ensuring adequate reporting of adverse events/technical complaint/compliance issue in accordance with company procedures.
- Ensuring all activities of associates comply with company standards and local regulations.
- Guaranteeing a timely and effective communication and escalation process is adhered to by all personnel.
- Developing and implementing Quality procedures and technical guidance in the US.
- Maintaining the Quality system, working procedures and Quality documents.
- Leading pharmacovigilance activities in the US and ensuring compliance training is achieved in the US.
- Implementing and maintaining the local Quality system/procedures in GxP areas.
- Ensuring QMS is maintained for document management, training management and electronic compliance in the US.
- Updating existing systems and processes and advocating for continuous improvement of Quality.
- Driving continuous Quality improvement in collaboration with relevant functions.
What you will bring:
These are the skills and experience you will need to succeed as the Director of Quality:
- Demonstrable leadership skills and ability to communicate with people of all levels.
- Strong stakeholder engagement and management skills.
- Ability to work both autonomously and in a cross-collaborative environment.
- Possess the ability to shape their own position and manage urgent FDA filing and inspections.
- Experience in designing, shaping and implementing policies, procedures and training across Quality Systems, Regulatory Compliance and Health Authority Inspections.
- Minimum of 5 years working in a leadership role or similar.
- Minimum of 15 years Quality Management/Regulatory Affairs/Manufacturing experience in the pharmaceutical industry or other regulated industry.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Bonus – STI and LTI
- Relocation assistance
Got what it takes?
To apply for the Director of Quality, click the ‘Apply’ button below or contact the Executive Search Consultant – Katy Barber – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.