Job Description

Title: Packaging Engineer (Direct Materials Management Quality Assurance Specialist

Locations: Hillsboro or Mississauga

Duration: Regular Full-Time Role

Type: Individual Contributor Role

Number of Positions: 1

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action; we believe that good business means a better world.

About the Job:

End to End Product Quality:

End-to-End Product Quality's goal is to enable faster launches and the delivery of compliant products to patients. End-to-End Product Quality will incorporate quality into the process through early collaboration with partners to support make-assess-release activities and to proactively mitigate errors from product development to divestment.

End-to-End Product Quality is responsible for:

Control Strategy and Execution, focused on Quality Control related activities with contributions from Reference Standard Management, Direct Materials Management, and Analytical Science

Compliance Monitoring, which is focused on processes, compliance and reporting with contributions from Global Issue Management, CAPA/Change Management, APQR and Complaint trending

Product Health, which is focused on Product Quality with contributions from Product Health Management, Filing Leadership and Device Design Quality.

The Direct Materials Management Chapter is accountable for direct material lifecycle and analytical expertise of direct materials. This includes Management of Supplier and Internal Release Specifications, Regulatory Filings and related Product Certifications

Your Key Accountabilities:

Accountable for managing activities related to direct materials and/or drug products/substances

Lead and execute process improvement projects.

Troubleshoot and direct the resolution of complex quality issues.

Involved in complex negotiations with internal and external stakeholders

Accountable for building collaborations and work relationships between the team members, stakeholders and user groups; External Quality (Distribution Quality, Affiliate Quality, CMO Quality etc.), Procurement, Planning, Material Science & Technology (MSAT), QC, QA, Manufacturing, Development (PTI, PTD, Packaging and Device Development etc.) and Regulatory

Monitors DMM activities and their effectiveness and efficiency; provides suggestions for process improvements, efficiency increases and possible cost reductions

Strives to achieve defined Key Performance Indicators (KPIs) for DMM

Participates in process improvement squads and activities

Supports quality oversight activities

Maintains a state of inspection readiness at all times

Supports internal and external audits as required

Responsible for authoring, reviewing and/or approving compliance / technical /scientific documents incl. Direct Material Specifications, Certification Documents for Products and Direct Materials

Responsible for owning and/or assessing planned/unplanned events

Responsible for implementing compendia changes and/or changes related to health authority audits

About You:

B.S/M.S degree (Preferably in Science or Engineering related fields) with at least 5 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience

Must possess project management skills. Experience working in/leading teams in a global setting

Effective communicator with various levels of the organization, demonstrating strong written and verbal communication skills including the ability to customize information for various audiences

Demonstrated influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner

Ability to lead moderate to complex projects. Demonstrated ability to create and manage work plans, timelines and accommodate multiple priorities

Working knowledge of analytical methods, instrumental technologies, method validation, or inspectional procedures for materials

Working knowledge of ICH guidelines, ISO standards or other international standards, Pharma GMP operations and Health Authorities regulations

Ability to interpret and follow Roche Quality standards

Knowledge and use of Quality Systems such as CAPA's and Change Management

Basic Knowledge of Operational Excellence tools desired; e.g. statistical methods, FMEA, Six Sigma, Lean Principles

Strong quality orientation with attention to detail and delivery of service excellence

Language: English and German preferred

Candidate may be required to travel approximately 10% of the time

The Mindsets we're looking for: inclusivity, Speaking-up, coaching others, focusing on outcomes, continuous learning, shared accountability

Great to have: Engineering degree with experience in Primary Packaging/Device materials for biologics

This position is not eligible for relocation support.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.