Do you have experience leading and driving all Operational Quality Assurance (QA) activities?
Are you looking for an opportunity to ensure that business goals are met, and the level of Quality remains high?
Are you located in Bangalore, India, or are you willing to relocate?
Fraser Dove International is partnering exclusively with an established biologics organisation specialising in the development of advanced therapies for chronic diseases. Operating worldwide, they are committed to enhancing global healthcare.
Our client is seeking a self-motivated leader to take responsibility for product quality and compliance of operations.
Discover more about our Quality Assurance Head, Drug Substance (Vice President) opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Quality Assurance Head, Drug Substance (Vice President), you will be measured against the following objectives:
1) Being accountable for product quality, compliance of operations, and executing and continuously improving any related activity.
2) Fostering a right-first-time culture across operations.
3) Implementing BBIL Quality management system and proposing improvements.
What you will do:
As the Quality Assurance Head, Drug Substance (Vice President), your duties and responsibilities will include:
- Leading and driving all Operational QA activities for allocated perimeter, ensuring products manufactured have the expected level of quality.
- Ensuring all-time inspection readiness of operations per scope, including preparation to regulatory inspections.
- Driving quality management reviews.
- Ensuring consistency, standardisation, efficiency, and cost-effectiveness of approaches while always maintaining compliance with regulatory and clients’ expectations.
- Defining, implementing, and monitoring the quality strategy for the allocated perimeter whilst relentlessly seeking best practices and improvements.
- Ensuring a proper organisational design to best meet customers’ needs.
- Leading, managing, developing, and coaching the team by fostering the right behaviours and mindset.
- Closely interacting with all business functions to ensure effective contribution to BBIL ambition.
- Actively participating in the Quality Leadership Team and leading cross-functional initiatives.
What you will bring:
These are the skills and experience you will need to succeed as the Quality Assurance Head, Drug Substance (Vice President):
- Ability to make clear decisions, appropriately balancing risks versus consequences.
- Strong leadership skills with the ability to get the buy-in of multiple stakeholders.
- Ability to work under pressure and cope with multiple priorities.
- Proactive and motivated with a clear passion to drive change and make significant improvements.
- Extensive knowledge of worldwide, applicable Quality regulations (US, EU, Brazil etc.)
- Strong understanding of Biologic Drug Substance manufacturing processes.
- Minimum of 20 years’ experience in multinational pharma/biopharma organisations, covering multi-site Operations/Quality roles with significant international experience.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Relocation assistance
Got what it takes?
To apply for the Quality Assurance Head, Drug Substance (Vice President), click the ‘Apply’ button below or contact the Executive Research Manager – Kaitlin Francis – 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.