CMO Quality Site Manager Specialist

Roche; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading company in healthcare is seeking a Quality Assurance Specialist to oversee compliance and quality at Contract Manufacturing Organizations. Utilizing your extensive knowledge of GMP regulations and project management, you will ensure high-quality product delivery while partnering with external organizations. This role values continuous improvement and offers you the chance to make a significant impact on public health.

Qualifications

• 5-7 years of progressive experience in biopharmaceuticals or related industry.
• Sound knowledge of pharmaceutical quality control analytics.
• Expert in international GMP regulations (FDA, EMA, ICH guidelines).

Responsibilities

• Serve as primary Quality SPoC for CMOs and CLOs.
• Ensure cGMP compliance across all activities.
• Lead investigations of discrepancies and manage technical changes.

Skills

Quality Assurance

FDA Regulations

Data Collection

Root Cause Analysis

Quality Management

Education

B.A. or B.S. degree in life sciences or related field

Tools

MS Office

Job description

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

A healthier future. Its 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.

Thats what makes us Roche.

As an individual contributor in Pharma Technical Quality (PTQ) you will apply your extensive experience in pharmaceutical manufacturing and quality control to ensure the delivery of highquality products and operational excellence. Driven by a passion for quality continuous improvement and excellence in you will act as the primary Single Point of Contact (SPoC) for designated Contract Manufacturing Organizations (CMOs) and will leverage these external partnerships to maximize global network capability while providing comprehensive Quality and Compliance oversight to reliably deliver products to patients.

The Opportunity :

Serve patients through external partnerships as the primary Quality Single Point of Contact (SPoC) for designated Contract Manufacturing Organizations (CMOs) and Contract Lab Organizations (CLOs) managing the relationship throughout their lifecycle.

Provide comprehensive Quality and Compliance oversight for Roche products at CMOs / CLOs ensuring cGMP compliance across all activities including technical transfer validation and ongoing manufacturing packaging and testing.

Apply your profound QC expertise you will lead related investigations managing discrepancies technical changes CAPAs arising from CMO / CLO activities and ensure timely closure

Oversee Make Assess Release (MAR) activities and maintain Quality Agreements with CMOs

Author review and approve manufacturing and QC technical documents from contract organizations such as batch records protocols reports deviations and Annual Product Quality Reviews.

Provide scientific and technical support to Health Authority (HA) regulatory submissions and responses to HA information requests potentially interacting directly with HAs on specific topics.

Support the stability testing program at CMOs including approval of protocols reports and related change requests and manage critical reagents / reference standard supplies and forecasting for contract organizations.

Oversee and coordinate the implementation of global Roche QC initiatives at contract organizations.

Who you are

You hold a B.A. or B.S. degree in life sciences or a related scientific discipline.

You possess sound knowledge of pharmaceutical Quality Control analytics and control systems.

You have 57 years of progressive experience in the biopharmaceutical or related industry or an equivalent combination of education and experience.

You are an expert in international GMP regulations including USA (FDA) EU (EMA; MHRA) and ICH Guidelines.

You are experienced in managing quality and GMP compliance issues.

You are proficient in crossfunctional stakeholder management and have strong project management skills including team leadership consultative facilitation conflict resolution and planning multiple concurrent projects.

You are highly competent in MS Office applications (Excel PowerPoint Word MS Project) fluent in oral and written English and preferably experienced with contract manufacturing organizations.

Travel :

Travel is required about 510 mostly regionally

Relocation benefits not eligible for this position

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience :

Chief

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1

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