Senior QA Supplier Manager

The Senior Quality Supplier Manager is responsible for a wide range of activities/tasks related to the quality oversight of external suppliers in charge of the manufacturing activities for a product. Acting as a single point of contact with the external supplier the Senior Quality Supplier Manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations the Quality Technical Agreement and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and crossfunctional relationships with Sobi stakeholders and will serve as deputy for Head of Quality NA.

We are excited to invite applications for the Senior Quality Supplier Manager position a fulltime remote opportunity. To be considered candidates must reside in North Carolina. In this role you will have the flexibility of remote work with the added opportunity for occasional travel as needed.

Key Responsibilities

• Act as single point of contact for all qualityrelated activities with the external supplier.
• Ensure that all aspects of handling manufacturing and distribution of products are in compliance with Sobi Quality System the effective Quality Technical Agreement and that they meet relevant cGMP regulatory requirements.
• Lead external supplier qualification.
• Establish Quality Technical Agreement and ensure valid QTA clearly defines roles & responsibilities between Sobi and the external supplier.
• Implement and maintain Quality Risk Assessment and KPIs on quality external activities.
• Define & monitor remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product quality performance.
• Request review GMP GDP documentation as defined in the QTA and Sobi procedures.
• Ensure external supplier provides product reviews or data (APQR/PQRs stability reports) as specified in the QTA.
• Assess the performance of the product and the process as per Sobi requirements.
• Manage/approve quality issues (deviations CAPA and complaints) as per QTA and Sobi requirements.
• Responsible for ensuring change requests either from the external supplier or from Sobi are managed according to the QTA and Sobi requirements.
• Responsible for ensuring Quality Audits of the CMO are performed according to Sobi requirements and the QTA.
• Define strategy of implementation and monitoring of key quality transformation initiatives and align with all process stakeholders outside of the Quality organization.
• Act as quality representative in projects related to external supplier e.g. Tech Transfer Launch.
• Assess and ensure external supplier readiness for Health Authorities inspections.
• Support inspections/audits of Sobi.
• Responsible for informing Sobi management and crossfunctional teams of all critical & major issues and escalating any issues as per Sobi escalation policy.
• Ensure good collaboration is maintained within the product team.

Qualifications :

• Bachelors 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 preferably other regions such 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 riskanalysis and problemsolving skills.
• Have interpersonal and leadership skills with the ability to influence external suppliers and crossfunctional teams to foster open and collaborative discussions around difficult decisions and impactful solutions.

Additional Information :

The base salary pay range for this role is $130000$150000 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 longterm incentives medical dental vision STD/LTD and life insurance benefits in addition to other health and wellness programs and offerings.

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex disability age sexual orientation gender identity or national origin. Sobi is committed to providing access equal opportunity and reasonable accommodation for individuals with disabilities in employment its services programs and activities.

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 COVID19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations as well as any statespecific exemptions as required by applicable law.

If you are interested in being considered for this role then please attach an updated copy of your resume (as a MSWord or PDF file) while submitting your application.

Why Join Us

We are a global company with over 1700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 firsthand 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 groundbreaking 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 cant 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. 

COVID19 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 COVID19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations as well as any statespecific exemptions as required by applicable law.

Remote Work :

No

Employment Type :

Fulltime