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 solutions.

Additional Information

The base salary pay range for this role is $105,000-125,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. 

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.