QA Portfolio Development Manager ESO

POSITION PURPOSE

The QA Portfolio Development Manager ESO manages all quality aspects of projects aimed to develop the portfolio of ESO products. Participates to launch management meetings and provides quality evaluation for projects lead by BD (In Licensing department and local BD) and also for projects linked to existing products. The QA Portfolio Development Manager ESO leads projects and is the quality SPoC and SME, responsible for escalation and solution preparation for non-standard project.

KEY RESPONSIBILITIES AND DUTIES

• Assure cooperation with Launch Management, In licensing / local BD, and other stakeholders responsible for new business and for improvements of current business. Evaluate new projects from Quality point of view and participate to launch management and/or In licensing/ local BD meetings (if applicable).
• Assure and manage the smooth transfer of new launches to a ESO QA Specialist. Support launch preparation and reescalation to launch management if and when necessary.
• Conduct external audits in line with valid audit plan of CMOs.
• Creation of internal SOPs.
• Participate to ESO Quality management meetings
• Identify gaps and propose solution to support BD, LM and other departments in case of non-standards portfolio development cases
• To propose organizational and operational solutions in case of portfolio development and market extensions and transversal projects set up.
• To participate on project linked to the portfolio lifecycle management and development.
• Support preparation of external audit plan.
• Reporting of KPI and launch status.
• Assure the accuracy of ESO product portfolio database and maintained up to date.
• The employee will perform other tasks under the direction of the Manager within the agreed type of work.

QUALIFICATIONS & REQUIRED SKILLS

• University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
• Minimum of 5 years of Quality Assurance experience in a GMP related environment
• Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
• Proven track record of project management skills
• Strong communication skills and negotiation strength
• Management of subcontractors is an advantage
• Sense of urgency, high autonomy & agile personality
• Proactive attitude
• Problem solving skills
• Hands-on attitude, flexible and open minded
• Collaborative and team-spirited
• Knowledge of IT tools
• Language - English: Advanced level

Our Recruitment Process: 

To be considered for this role, please apply in our Applicant tracking system and refrain from sending your CV via email. Upon the completion of sourcing (CV collection) period, all received application will be reviewed by our Recruitment experts and evaluated against the needs of the open role. Successful candidates will be contacted by our Recruiting experts for an initial screening interview during which further details about the selection process will be shared. Successful candidates will progress to interviews with line managers, while not selected candidates will be informed in a written form as soon as possible. 
 
Diversity is a fact. Inclusion is an act @Zentiva  
 
At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. 

Join our winning team Be a part of our winning culture Be Zentiva