Principal Quality Technical Manager, Quality Control

The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)

The Opportunity

The Opportunity:

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 service the site and the region.You are accountable for direct material lifecycle and analytical expertise ofdirect 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..

• 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 improvementto 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, is responsible for CAPA actions, implementing compendia changes, performs problem solving, & monitors 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 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 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 professional level written and oral communication skills required

Preferred:

• Operational excellence and industrial engineering skills

• You are proficient in the German language

• You have a mindset of (1) Inclusivity (2) speaking up (3) coaching others (4) focussing on outcomes (5) continuous learning (6) shared accountability.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $113,00 - $209,000. 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 not provided

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