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Head of Quality, Canada
A career with EMD Serono is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
The Quality Manager will lead and manage all quality and compliance related aspects for Canada with regards to GMP and GDP in alignment with the strategy defined with the business and global quality functions.
Main areas of responsibility are:
- Implementing a Quality Management System (QMS) at the subsidiary based on Corporate and Global company standards and procedures, international and local applicable GMP and GDP regulations
- Build quality awareness at local management and ensure that local management and functions fulfil them role with regard to quality requirements as defined in the applicable regulations
- Monitoring and Reporting quality performance indicators to management and take leadership in the performance of Quality Management Reviews
- Managing the Quality Department team that covers all GMP/GDP quality tasks
- Manage quality related aspects of company GMP/GDP vendors and partners in the country
- Liaise with quality global functions (MS-Q) and report status of quality systems implementation, KQI and quality issues
- Implement a quality risk management process on the QMS processes
- Manages the budget for local GMP/GDP Quality activities
- Assure that company standards and local regulations are implemented and followed by all employees of the subsidiary
- Manage and follow up quality inspections held by local Health Authorities
- Defend company positions regarding quality issues at the local Health Authorities
- Assure external GMP/GDP partners in compliance with company standards and local regulations
SCOPE OF PEOPLE RESPONSIBILITY
- Management of local Quality Team
- Overseeing external providers (GMP/GDP partners, CMOs and Distributors)
- Act as interface between Global Quality and the local organization
- Describes if communication is mainly focused on internal or external contacts
- Local Country organization
- Biopharma Quality
- R&D Quality
- Regulatory Affairs
- SNO organization
- Health Authorities
- Contract Manufacturing Organizations
- Warehousing and Distribution 3rd parties
Who You Are:
- Doctorate or academic degree in natural or applied sciences (Pharmacy, Chemistry, Engineering, Biotechnology) from a recognized Canadian University
- Minimum of 7 years work experience in quality assurance and/or quality control and/or production/distribution in the pharmaceutical industry – ideally in a commercial subsidiary
- Thorough knowledge of GMP, GDP and applicable local regulations
- Demonstrated good interpersonal skills
- Demonstrated good written and verbal communication skills
- Demonstrated good presentation skills
- Problem Solver and Solution oriented
- Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
- Analytical skills, quick perception and good judgment
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.