GxP Supplier Quality Manager

Genentech; Louisville (KY); On-site; USD 90,000 - 163,000; Full time

Job summary

This innovative firm is seeking a dedicated professional to join their Pharma Technical Quality team. You will play a crucial role in ensuring the delivery of high-quality pharmaceutical products while overseeing compliance and operational excellence. Your expertise in pharmaceutical manufacturing and quality compliance will be essential as you manage relationships with external partners and internal teams. With a focus on continuous improvement and patient access, this role offers the opportunity to make a meaningful impact in the healthcare sector. If you are passionate about quality and thrive in a collaborative environment, this position is perfect for you.

Qualifications

• 5 years of experience in biopharmaceutical industry or equivalent.
• Sound knowledge of Batch Release activities and compliance.

Responsibilities

• Oversee delivery of high-quality products and operational excellence.
• Provide Quality and Compliance oversight at Contract Manufacturing Organizations.

Skills

Pharmaceutical Manufacturing

Quality Compliance

Batch Release Activities

MS Office Applications

Investigation Expertise

Education

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

Tools

MS Excel

MS PowerPoint

MS Word

MS Project

Job description

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Position:

In this individual contributor position you will be part of Pharma Technical Quality (PTQ) and will oversee the delivery of high-quality products and ensure operational excellence. You will be an experienced professional in pharmaceutical manufacturing and compliance. You should be able to leverage 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:

• You will serve patients through external partnerships to ensure access to quality products and offer flexibility to internal capacity.
• You will provide Quality and Compliance oversight for Roche products at Contract Manufacturing Organizations (CMOs), ensuring cGMP compliance.
• You will act as the Quality Point of Contact (PoC) for Batch Release of materials produced by Roche’s CMOs.
• You will manage Make Assess Release (MAR) activities.
• You will collaborate with CMO and internal teams, managing relationships and resolving quality issues.
• You will 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.
• You will bring 5 years of progressive experience in the biopharmaceutical or related industry or an equivalent combination of education and experience. Preferred experience with contract manufacturing organizations.
• You will have sound knowledge of Batch Release activities performed internally and by CDMOs/CLOs.
• You need to be highly competent in MS office applications including Excel, Powerpoint, Word, MS Project, etc.
• Fluent in oral and written English is a must.

Travel:

• Travel is required about 5%, mostly regionally.

Salary and Benefits:

The expected salary range for this position based on the primary location of Kentucky is $90,600 to $162,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.