South San Francisco, California
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
Main Purpose of the Position:
* The purpose of this position is to provide quality oversight and
expertise for the implementation and management of Quality Systems in
contract manufacturing organization used for the manufacture of
clinical and commercial biotech drug product.
* The Technical Manager is responsible for the operation of the Change
and Deviation/CAPA Management Systems in External Quality
Operations. Working with GNE Site Managers, this position will
manage the process by which Genentech’s evaluation of changes and
deviations is performed. This position will be responsible for the
operation, documentation and evaluation resulting from Review Boards
(CAPA Review Board, CRB and QRB). The Technical Manager will review
CMO documentation and relevant assessments and will work with Site
Managers, the External Review Boards, and other business unit to
ensure that changes/deviations/CAPAs are evaluated to a consistent
standard and in accordance with applicable policies and procedures.
In addition, the Technical Manager will support execution of Quality
Systems in the department and represent cross function teams.
Job Duties/Responsibilities:
* Follow company policies and procedures.
* Maintain a state of inspection readiness.
* Set personal performance goals and provide input to departmental objectives.
* Establish work priorities to meet targets and timelines.
* Independently manage competing priorities and allocate, adjust and optimize assigned department resources.
* Independently manage competing priorities with limited instruction.
* Serve as the Quality representative on cross-functional and multi-site teams.
* Identify, design, and implement process and system improvements.
* Lead and participate in the design and implementation of department and cross-functional initiatives.
*
Apply advanced theory, technical principles, expert judgment and
cross-functional expertise to independently address a broad range of
difficult problems.
* Troubleshoot and direct the
resolution of Quality issues by fostering effective interdepartmental
and cross-functional partnerships.
* Serve as a technical subject matter expert (SME) in support of department functions.
* Collaborate and author department policies and procedures.
* Make decisions that impact the goals and objectives of the department.
* Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
* Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
* Perform any other tasks as requested by Management to support Quality oversight activities.
Technical Duties/Responsibilities:
* Represent External Quality on cross network Quality System
Teams.
* Ensure that established quality systems are maintained,
measured, implemented and controlled for use in GMP Environment.
* Maintain system elements and documentation to ensure the
requirements of the Quality Agreement are fulfilled.
* Review and determine CAPA/Investigation/Change plans to ensure
quality requirements are met prior to GMP processing.
* Review and approve quality system documentation for compliance to
regulatory filings, product requirements and cGMP compliance.
* Support tasks involving person in the plant to provide
Genentech oversight of the CMO quality unit in order to facilitate
timely initiation, assessment, review and closure of discrepancies
and investigations.
* Review executed CAPA/Investigation/Change records, assess trends
and effectiveness.
* Build strong relationships with both internal operations units and
external CMOs and partners.
* Participate in risk assessment of CMO's Quality Systems for
clinical and commercial.
* Provide improvement inputs in quality system by measuring and
maintaining department KPIs. Coordinate requirements within the
department.
* Review documentation for regulatory filings or quality filings.
* Participate in the design, implementation and maintenance of
quality systems for execution of the above functions.
Who You Are
* BS or BA in a relevant scientific discipline or equivalent and
demonstrated working knowledge of Quality Assurance and manufacturing
principles.
* At least 8 years pharmaceutical experience with biotech/small
molecules is required; experience in manufacturing is desired.
* At least 4 years direct experience in quality assurance for
pharmaceutical operations is strongly preferred.
* Sound knowledge of cGMPs and an ability to apply sound judgment and
decision making skills (risk based and appropriate) in order to
evaluate product release is necessary. Sound knowledge of Quality
Systems is essential and understanding of cGMP regulations.
* Strong time management skills and ability to prioritize own work.
* Experience reviewing change and deviation/CAPA records.
* Excellent written and verbal communication skills.
* Strong interpersonal skills and negotiation skills.
* Outstanding interpersonal, influence, initiative, task management,
and conflict management skills.
* Ability to manage multiple, changing priorities in a fast-paced
environment is essential; strong attention to detail required.
* Ability to travel up to 10%, including international travel.
Genentech is an Equal Opportunity Employer.
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