Principal Product Steward

South San Francisco, California

Job ID: 00425771

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Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

Position Overview
Quality product leaders (QPL) are responsible for the product quality lifecycle management and quality related global activities for the commercial product.  The QPL is a member of the TPT, which is accountable for the launch and lifecycle management of the product working as a matrix team across the PT organization. QPL works cross-functionally in a matrix setting with a xxx for PT for the assigned molecule/product, providing leadership for all quality activities. Partner and influence with TPT, PRC and Q LT to develop and implement a product lifecycle vision strategy and plan.
Responsibilities
•          Manage overall commercial product quality lifecycle
•          Serve as SPOC for product quality within PT
•          Represent Quality on Technical Product Teams (TPT)
•          Lead, manage product quality sub team (PQST)
•          Provide quality  perspective and expertise to TPTs and PT organization
•          Develop Product Quality Plan (PQP)
•          Develop quality product strategy in alignment with overall PSP (product strategic plan)
•          Accountable for product quality sub team decisions
•          Drive global quality activities to ensure continuous supply to patients
•          Drive the completion of quality deliverables through the leadership of the PQST
2. Manage Commercial Product Quality Lifecycle
•          Provide direction and influence product quality decisions
•          Provide recommendations and influence decisions to ensure quality supply to patients (e.g. GEG, QRB, BQC, SMQC, LSTDC)
•          Ensure alignment of quality related activities to meet product goals and long term plans
•          Proactively communicate significant quality issues and/or risks
•          Identify and drive quality risk mitigations
•          Communicate quality requirements
•          Provide quality input into product sourcing decisions and ensure aligned QC analytics strategy
•          Support product transition from clinical to commercial, new product introductions and tech transfers
•          Support product regulatory filings and product approval inspections
•          Ensure alignment of product changes in support of Product Quality plan (PQP)
3. Product Health
•          Define and monitor product quality health metrics
•          Approve APQR* and report PQMR
•          Propose product improvement activities
Key Product Quality Deliverables
•       Product Quality Plan (PQP)
•       E2E quality risk assessment and mitigations
•       PQMR Product Quality Management Review
•       Product health metrics & reporting
•       PQS deliverables (MPS, PHF, iCQAG,)

1. Leadership

•        Proven leader - based on Roche leadership commitments.  Demonstrated ability to build and lead successful cross-functional teams
•          Strong collaboration skills and ability to influence without direct authority.
•          Past results are indicative of consistently sound and effective quality decisions.
•          Outstanding partnership skills with proven experience in identifying opportunities that have improved results across the organization.
•          Excellent organizational agility and interpersonal savvy: knows how to get things done in a way that optimizes results, strengthens internal and external relationships, and puts the least pressure possible on resources. 
•          Consistently demonstrates managerial courage to ensure quality and compliance supply to patients.   
•          Domestic and international travel (20%)
2. Communication and interaction
•          Effective communicator at all levels and excellence written, oral and interpersonal communication skills
•          Build and maintain constructive and effective relationships with internal and external customers, stakeholders, peers and team members,
3. Decision making
•          Consistently demonstrate sound Quality judgment and right balancing between business, supply and quality needs when making decisions.
•          Identify product issues and leads resolutions
•          Ability to effectively influence decision makers
4. Complexity management
Deal with concept ambiguity and complexity skillfully and can effectively influence others across all levels of the organization
5. Results and orientation
•          Sound problem solving skills with proven ability to recommend effective and efficient solutions

Who You Are

•       12 years experience working in pharmaceutical or related industry
•       5 + years of people management or matrix team leadership experience
•       BA / BS/ MS Degree (preferably in life sciences or engineering)
•       Strong knowledge of cGMPs, HA regulations, Quality Systems and technical expertise in DS/DP manufacturing process.
•       Knowledge of devices and device development desirable.
•       International/global experience strongly preferred
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.