GxP Supplier Quality Manager

Scorpion Therapeutics; United States; Remote; USD 90,000 - 163,000; Full time

Job summary

An established industry player is seeking a dedicated professional to join their Pharma Technical Quality team. In this pivotal role, you will ensure the delivery of high-quality products while overseeing compliance and operational excellence. Your expertise in pharmaceutical manufacturing and contract organizations will be crucial in maintaining standards and resolving quality issues. This is a fantastic opportunity to contribute to a healthier future for patients, all while working in a collaborative environment that values innovation and quality. If you are passionate about making a difference in healthcare, this role is for you.

Qualifications

• 5+ years of experience in the biopharmaceutical industry.
• Knowledge of cGMP compliance and quality oversight.

Responsibilities

• Oversee delivery of high-quality products in compliance with regulations.
• Manage relationships with Contract Manufacturing Organizations.

Skills

Pharmaceutical Manufacturing

Quality Compliance

Batch Release Activities

MS Office (Excel, PowerPoint, Word, Project)

Contract Manufacturing Knowledge

Fluency in English

Education

B.A. or B.S. in Life Sciences

Tools

MS Office

Job description

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The Position

We are committed to creating a healthier future by continuously advancing science and ensuring access to healthcare for all. Our goal is to create a world where everyone has more time with loved ones. That’s what makes us Roche.

The Position

In this individual contributor role within Pharma Technical Quality (PTQ), you will oversee the delivery of high-quality products and operational excellence. You should be experienced in pharmaceutical manufacturing and compliance, capable of leveraging external partnerships to maximize global network capability and reliably deliver products to patients. Driven by a passion for quality and continuous improvement, you will ensure flexibility, compliance, and excellence in execution.

The Opportunity

• Serve patients through external partnerships to ensure access to quality products and provide flexibility to internal capacity.
• Provide Quality and Compliance oversight for Roche products at Contract Manufacturing Organizations (CMOs), ensuring cGMP compliance.
• Act as the Quality Point of Contact (PoC) for Batch Release of materials produced by Roche’s CMOs.
• Manage Make Assess Release (MAR) activities.
• Collaborate with CMO and internal teams, managing relationships and resolving quality issues.
• Provide batch release expertise in investigations and ensure timely closure of deviations, complaints, and CAPAs.

Who you are

You will have a B.A. or B.S. degree in life sciences or a related scientific discipline, with 5 years of progressive experience in the biopharmaceutical or related industry, or an equivalent combination of education and experience. Preferred experience includes work with contract manufacturing organizations. You should have sound knowledge of Batch Release activities performed internally and by CDMOs/CLOs. Proficiency in MS Office applications such as Excel, PowerPoint, Word, and MS Project is required. Fluency in oral and written English is a must.

Travel

Travel is approximately 5%, mostly regionally.

Salary Information

The expected salary range for this position in Kentucky is $90,600 to $162,200. Actual pay will depend on experience, qualifications, location, and other factors. A discretionary annual bonus may be available, and benefits are detailed at the link below.

Benefits

Genentech is an equal opportunity employer. We promote and treat employees based on merit, qualifications, and competence. Discrimination based on protected veteran status, disability, or other protected categories is prohibited. For accommodations related to the application process, please contact us through the provided form.