Director Quality ACE Compliance QP and Product ComplaintsNetherlands - AmsterdamQualityRegular
Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We are seeking a highly motivated individual to join us as Director, Quality in the Product and Distribution Quality (PDQ) team to lead ACE Compliance, QP and Product Complaints. The Director will report to the Executive Director of Product & Distribution Quality.
This role will play a pivotal role within our technical operations organization with accountability to assure compliant process, patient lot QP release and implement continuous improvements to keep pace with changing regulations and growing competitive market demands.
In this position, you will lead staff and processes that have quality impacting roles on product and distribution. This role will partner within the ACE region with Site Qualification, EU manufacturing facility and Affiliate staff, in addition to representing PDQ on global Quality steering committees.
Your Responsibilities will be (included but not limited to):
- Provide leadership and direction for staff in roles of Qualified Person and Responsible Person for ACE region
- Lead and manage the Affiliate and RA/QA interactions including training, ongoing forums.
- Manage EU region product complaint process for intake, investigations and closure, and coordinate trend reporting with global product complaint team.
- Provide compliance leadership in the ACE region for Tier meetings, regional launch leadership meetings, emerging issues, etc. with understanding of the global impacts and regional requirements, collaborating globally as determined.
- Ensure Quality records are initiated, investigated/evaluated and resolved/implemented as assigned to team and provide leadership to investigate or evaluate as warranted
- Lead, develop, mentor and manage staff
- PDQ representative on the Global Quality Systems and Compliance Steering Committee
- Participate and/or assure staff and processes prepared for regulatory agency inspections (eg, EMA, TGA, HC, FDA)
We are looking for an experienced candidate with strong leadership capabilities, compliance and quality management systems expertise, combined with excellent collaborative skills to work with the Affiliate partners and regulatory agencies.
- Master’s degree in the biological sciences + 10 years’ progressive quality or manufacturing experience in a pharmaceutical or biologics operation OR
- Bachelor’s degree in the biological sciences + 12 years’ progressive quality or manufacturing experience in a pharmaceutical or biologics operation OR
- High School + 16 years’ progressive quality or manufacturing experience in a pharmaceutical or biologics operation
- 3+ years of management/leadership experience
- Working knowledge and ability to apply GMP in conformance to U.S., EU, HC, TGA and ROW standards
- Ability to effectively negotiate and build collaboration amongst individuals cross-site and cross-functional
- Experience with direct regulatory agency interactions
- Demonstrated ability to develop, coach, and mentor employees
- Ability to work effectively in a global, matrixed organization with multiple functions, together with a positive attitude, strong work ethic, professional maturity, and personal integrity
- Excellent interpersonal, communication (written and verbal), listening, and influencing skills
- Self-starter with a solutions and results-oriented mindset.
- Strong analytical, critical thinking and problem-solving skills
- Strong organizational and project management skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Up to 20% travel
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.