Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Quality organization at HTO comprises Quality Assurance, Quality Systems & Compliance, Quality Control, and Quality Engineering & Validation. Together, we produce millions of units of life-saving medicine every year to patients around the world.

The Opportunity:

Quality Control works in a very dynamic environment in both the commercial and new product technical transfer environments. The close networking with the local and global organization makes QC a key function in the E2E business. The Head of Quality Control is accountable for day-to-day operations at the site, for shaping network QC Strategy, and for implementing these strategies and anchoring sustainably within the site.

Leadership:

You will create an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation, and inspire teams to achieve short-term and long-term goals.

You will be an active and visible change agent and promote a flexible and open attitude towards new opportunities.

As a member of the Quality Site Leadership Team and the HTO Site Leadership Team, you will drive networking activities, coordination, cross-functional planning and decision making. 

You will be responsible for the overall budget and financial performance of the quality control department.

You will take proactive measures to promote a positive safety culture and ensure all applicable safety, health and environmental requirements are met in accordance with company policies and local legal requirements.

You will embody Pharma Technical (PT) Lean principles and methodologies and promote a continuous improvement culture throughout the organization by encouraging experimentation and learning.

Technical and functional tasks:

You will drive strategic efficiency measures for "Future QC" in close collaboration with Network QC representatives.

You will establish, modify, implement and enforce quality control policies, procedures, specifications and testing methods consistent with cGMP, regulations, relevant regulatory frameworks and Roche/Genentech standards, policies, plans, objectives and procedures.

You will ensure timely analytical transfers and local analytical method verifications according to site requirements.

You will lead the QC team to resolve issues in a timely manner, including discrepancies, investigations, and implementation of corrective and preventative actions (CAPA).

You will escalate potential quality issues identified during QC testing or processing of products, particularly quality or regulatory issues that could impact product quality or regulatory compliance.

You will support regulatory inspections and partner audits, as well as approval of protocols and reports from external QC laboratories.

You will coordinate with regulatory authorities and external sources and network partners regarding issues affecting product quality.

Requirements:

You hold a B.S/M.S degree (Preferably in Science or Engineering related fields) with at least 15 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.

You have extensive knowledge of analytical methods, instrumental technologies, method validation, or inspectional procedures for materials

You have several years of experience in a managerial position in a quality control environment, preferably in the pharmaceutical or biotech industry.

You have strong leadership and management skills as well as experience in cross-functional collaboration.

You have an in-depth understanding of cGMP, regulatory requirements and quality management systems.

You have excellent communication skills and the ability to inspire and motivate a team.

You have experience implementing and driving a continuous improvement culture.

You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $155,000 - $288,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

Relocation benefits are provided

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