What are the responsibilities and job description for the Associate Director, Supplier Quality position at Galapagos?
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.
We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.
We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The 'make-it-happener'.
We are looking for an Associate Director, Supplier Quality.
Scope of the job
The "Associate Director of Supplier Quality" is responsible for Quality oversight, qualification, and collaboration with complex GxP suppliers related to the Galapagos (GLPG) Supply chain. The scope of the role includes providing expertise in support of GMP compliance and technical Quality, with an emphasis on suppliers who provide critical materials or services (including lentiviral vector) for products at mid-stage of development or later.
The Decentralized Manufacturing Units (DMUs) supporting the Cell Therapy drug product manufacturing network are not in scope for this role.
Your role
Lead and direct all aspects of driving effective product quality and ensuring a high level of GMP compliance at critical suppliers in the GLPG supply chain, to ensure high level to patient safety, product quality, and regulatory success are routinely met for Galapagos Cell Therapy products.
This includes :
- Ensuring a consistent supply of critical materials and / or services by implementing effective Supplier Quality programs, including risk-based processes for achieving and maintaining Supplier Qualification.
- Ensuring collaborative and productive Quality-to-Quality relationships are in place, to monitor performance effectively and jointly meet agreed targets outlined in approved Quality Agreements and / or agreed in other governance mechanisms.
- Ensuring processes are established and utilized for effective issue resolution, to include appropriate escalation mechanisms as needed.
- Leveraging standard supplier management processes (e.g., Supplier Initiated changes, deviation and complaint management, KPI monitoring) to understand risk profile for key suppliers.
- Implementing and managing mitigation plans to mitigate risks to product quality and GMP compliance in a timely manner to ensure uninterrupted supply.
- Driving jointly agreed improvement projects to maintain and enhance the performance standards necessary to achieve Galapagos' ambitions.
- Working cross-functionally in GLPG (e.g., other QA functions, Manufacturing, Supply Chain, MSAT, PD / AD, QC) to understand and respond as needed to performance-related observations, upcoming changes, and emerging risks.
- Author, review, and provide technical support as needed for investigations, change controls, product complaints and communications.
- As needed, provide support with staffing and deploying a team of Supplier Quality professionals with the appropriate level of capability to support the above responsibilities.
Who are you ?
EDUCATION AND EXPERIENCE
GENERAL SKILLS
What's in it for you ?
At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.
We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.
Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.
We are Galapagos : together we can make it happen...!
Base compensation for this position ranges from $ 129,000 to $ 215,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.
In addition, this position is eligible for participation in both Galapagos' performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.
Salary : $129,000 - $215,000
