Do you have a thorough knowledge of cGMPs and biotechnology-derived product regulations?
Are you looking to lead all Quality Operations and facilitate change management?
Are you located in the US, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a biopharmaceutical organisation providing drug development solutions. Operating worldwide, they are committed to accelerating their drug development programs to improve lives.
Our client is seeking a proactive leader to drive Quality up the agenda and take responsibility for a growing team.
Discover more about our Senior Director of Quality Operations opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Senior Director of Quality Operations, you will be measured against the following objectives:
1) Leading all Quality Operations and overseeing raw material inspection and release, reviewing quality control data and QA on the floor.
2) Managing internal auditing, change management, regulatory inspections, quality systems oversight and quality metrics reporting.
3) Coaching and mentoring a growing team and driving Quality up the agenda.
What you will do:
As the Senior Director of Quality Operations, your duties and responsibilities will include:
- Overseeing, developing, and improving quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured products.
- Creating QA policies and programs.
- Collaborating with other Quality Site Heads on continuous improvement initiatives.
- Leading, assessing and coaching departmental associates.
- Ensuring the Quality team meets expectations and objectives and providing personal guidance and training.
- Contributing to long-term strategic planning and part of site senior leadership team.
- Working with internal and external client teams to establish the Quality strategy, define roles and problem solve.
- Ensuring that a high quality of products is achieved through qualification and validation based upon quality risk analysis, product quality assessments and ongoing verification.
- Ensuring that facilities, equipment, and processes are operated consistently with current Good Manufacturing Practice (cGMP).
What you will bring:
These are the skills and experience you will need to succeed as the Senior Director of Quality Operations:
- Excellent leadership skills with an understanding of how best to utilise and deploy staff.
- Ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.
- A self-motivated individual with high energy and attention to detail.
- Results-driven with an overall proactive approach to daily responsibilities.
- Ability to read, analyse, and interpret the most complex documents.
- A thorough knowledge of cGMPs and biotechnology-derived product regulations.
- Bachelor’s degree in a scientific discipline with 8 years of Quality management experience.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Health insurance.
- Short and long-term bonus.
- Opportunities for career advancement in a growing organisation.
- Generous holiday allowance.
Got what it takes?
To apply for the Senior Director of Quality Operations, click the ‘Apply’ button below or contact the Executive Search Consultant – Peter Vedde – 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.