[Hiring] QA Supplier Senior Manager @Sobi
Mar 29, 2025 - Sobi is hiring a remote QA Supplier Senior Manager. 💸 Salary: $130,000-$170,000 annually. 📍Location: USA.
Role Description
The 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 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 cross-functional relationships with Sobi stakeholders.
- Please note this is a remote position with travel
Key Responsibilities
- Act as Single point of contact for all quality related activities at the External Supplier
- Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement, that they meet relevant cGMP regulatory requirement.
- Lead External supplier Qualification
- Establish Quality Technical Agreement and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier
- Implementation 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 requirement.
- Manage / approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement.
- 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 is performed according to Sobi requirement and the QTA.
- Define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization.
- Act as Quality representative in project related to External supplier eg Tech Transfer, Launch.
- Assess and ensure External Supplier readiness for Health Authorities inspections
- Support inspections/audits of Sobi.
- Responsible to inform Sobi management and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy.
- Ensure a good collaboration is maintained within the product team
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.
Benefits
- 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
Additional Information
The base salary pay range for this role is $130,000-$170,000 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.
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.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
💸
$130,000-$170,000 annually
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 29, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
