Clinical Quality Assurance Manager - Investigational Medicinal Product (IMP)

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

The Clinical Quality Manager is responsible for a wide range of activities/tasks related to the Quality oversight of external suppliers in charge of the manufacturing and related activities for Investigational Medicinal Product (IMP).  The Clinical QA Manager will provide leadership and guidance to Supplier Managers; as well as, assist in the development and implementation of quality systems related to IMP Quality oversight and product release.  Acting as a single point of contact with the external supplier, the Clinical Quality Manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Agreement and with Sobi procedures and policies. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders.

*Please note this is a remote position with travel

Key Responsibilities

• Coordinate a team of Quality, by providing leadership and expertise regarding IMP quality compliance.   Responsible for setting goals / objectives and conducting performance reviews.  
• Manage key performance indicators (KPIs) for operational Quality Assurance activities and services associated with the IMP suppliers and monitor the overall supplier performance as it relates to Quality Assurance activity.
• Serve as the central point of contact to the external manufacturers and internal stakeholders for organizing inquiries, deviations & investigations, and audit observations associated with the IMP suppliers.
• Ensure change requests and complaints are managed according to the Quality Agreement and Sobi requirements.
• Ensure all quality agreements are in place, perform revisions, and collaborate with internal stakeholders to ensure adherence to the Quality Agreements.
• Work cross-functionally and in collaboration with the various internal teams as necessary, including R&D/Medical Affairs, GCP/ GVP QA, and Product Quality Lead (PQL) teams on assessment, management and escalation of IMP quality and operational issues.
• Participate in recurring IMP supplier QA and cross functional team meetings and business review meetings to present issues impacting results and guide the team to resolution.
• Perform review of batch records of IMP products for use in US, EU and RoW clinical trials.
• Support IMP external supplier audits and ensure readiness for Health Authority IMP GMP inspections.

Qualifications

• Bachelor’s degree or equivalent education/degree in life sciences or healthcare with relevant area such as pharmaceutical, biotech or life science industry.
• More than ten (10) years of experience within pharmaceutical, biotech product.
• Extensive experience in QA operation, production or other relevant area (GMP, GDP)
• Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferable other regions as APAC, LATAM, etc
• Strong understanding of risk assessment and risk management fundamentals / tools
• Fluently spoken and written English
• Ability to travel approximately 25% of the time

Personal Attributes

• Have a solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
• Be comfortable in a global and dynamic environment where priorities shift often
• Be a highly diplomatic and tactful individual with excellent critical reasoning, risk-analysis, and problem-solving skills.
• Have interpersonal and leadership skills with the ability to influence external Suppliers and cross-functional teams to foster open and collaborative discussions around difficult decisions and impactful soluti