Senior Manager/Director, Quality Control (Direct Materials)

Organization Overview

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 Operations organization at HTO is divided into two manufacturing units, which combine to 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 organizations makes QC a key function in the E2E business.

In this exciting role, you are responsible for providing oversight and direction for the development, implementation, and maintenance of the HTO Direct Material QC Group, which will serve the site and the region. You are accountable for direct material lifecycle and analytical expertise of direct materials. You will perform activities such as Management of Supplier and Internal Release Specifications, transfer of methods, establishment of a testing footprint in HTO, Regulatory Filings and related Product Certifications, and establishing a program for the assessment, review and disposition of Direct Materials. You will collaborate across the site and network organization and will engage with stakeholders and business leaders in a technical leadership capacity. You will ensure the QC DM strategy for the site is technically sound and is in alignment with business objectives and regulatory requirements.

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 Control Leadership Team you will drive networking activities, coordination, cross-functional planning and decision making.

• 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 be accountable for managing activities related to direct materials and/or drug products/substances

• You will establish Direct Material operational performance measures; focus is on right first time execution and continuous improvement to meet business objectives

• You will be responsible for authoring, reviewing and/or approving compliance / technical /scientific documents incl. Direct Material Specifications, Certification Documents for Products and Direct Materials

• You will build 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

• You own deviations and change records, are responsible for CAPA actions, implement compendia changes, perform problem solving, & monitor operations.

• You will participate in the identification, evaluation, and implementation of new technologies in alignment with business objectives or regulatory requirements.

• You will have responsibility for strategic projects to support execution of QC network strategy.

Who you are:

• You hold a B.S/M.S degree (Preferably in Science or Engineering related fields) with the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience (12-15 years for the Sr Manager level or 16-19 years of experience for the Director level)

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

• You have working knowledge of ICH guidelines, ISO standards or other international standards, Pharma GMP operations and Health Authorities regulations

• You have proven technical leadership capabilities and demonstrated project management skills. Demonstrated ability to create and manage work plans, timelines and accommodate multiple priorities

• You have an ability to work effectively and efficiently with internal teams, partners, suppliers and customers.

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

Preferred:

• Operational excellence and industrial engineering skills

• You have a mindset of Inclusivity, speaking up, coaching others, focussing on outcomes, continuous learning and shared accountability.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $142,000 - $263,000 for the Director level and $122,00 - $227,000 for Senior Manager level. Actual pay will be determined based on experience, level, 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.

Link to Benefits

Relocation benefits are provided

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.

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