QC Sr. Supervisor

Job description

·  Job facts

Summary

As the Senior Supervisor of the QC Change Management and Discrepancy Management teams, the primary responsibility is to supervise and develop the staff to perform routine activities in accordance with cGMP regulations and Genentech standards to meet departmental and organizational goals. More specifically, to manage employee operations around discrepancy and technical change management. The following are additional responsibilities: represent the department in regulatory agency, internal and partner audits, provide technical expertise to resolve routine to complex QC issues, and to develop and conduct training for QC personnel. Lastly, supporting the department to establish robust work processes and assess for continuous improvement opportunities is a key function.

When acting in the role of Discrepancy Owner, Lead (DOL),responsibilities include acting as counsel and advocating for departmental compliance activities in alignment with our global and local standards and processes. In conjunction with Quality Control leadership, the DO Lead analyses documentation, training, behavioral trends, work execution, and performance metrics as they pertain to Quality and regulatory requirements.

Job Responsibilities

Leadership & People Management:

·  Lead/Manage Quality Control discrepant event assessments throughout the course of the discrepancy investigation. This includes, but is not limited to:
·  Manage each stage of the discrepancy investigation in alignment with due dates to ensure timely completion.
·  Performing Recurring Discrepancy Assessments
·  Performing Causal Analysis (Schedule/lead RCA activities as needed)
·  Ensure first, appropriate steps have been taken to protect people and product and that the system and process is in a stable state
·  Help to set the scope of the discrepancy and escalate issues impacting quality, efficacy and/or supply as appropriate to ensure resolution.
·  Communicate with key stakeholders to ensure all impacted areas are consulted and provide input based on area of responsibility.
·  Review discrepancy record for completeness/completion. Requests corrections/further clarifications needed in the record.
·  Oversee management of Quality Control Change Records throughout the lifecycle of the record, ensuring all quality requirements are met and timely completion.
·  Exhibit detail oriented documentation skills to ensure Right-First-Time operations
·  Comply with cGMP, SOP and QC documentation.
·  Be familiar with routine QC operations
·  Provide Quality Control support as it relates to make, assess and release demands.
·  Provide input into the design and presentation of departmental discrepancy performance metrics.
·  Train other QC personnel as appropriate. Contribute to the improvement of training material and practices
·  Follow established safety and environmental guidelines and procedures for all work performed.
·  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
·  Fosters safe work practices and champions safety improvements

Additional Requirements:

·  Demonstrate Roche Leadership Competencies within Department and to the site
·  Serve as an example and advocate of ingrained quality
·  Communicate effectively and professionally work in a team environment. Serve as department representative on cross-functional teams.
·  Participate in internal and external audits and regulatory inspections
·  Contribute to a LEAN work environment by acting as a change agent and utilizing OE Tools. Identify, design and implement process and system improvements.
·  Perform other duties as requested by managers to support Quality activities.

Job Requirements

Education:

·  BS/BA degree (preferably in Life Science) and at least five years of experience in the pharmaceutical, biopharmaceutical industry, or an equivalent combination of education and experience.

Experience

·  Sound knowledge of cGMP or equivalent regulations.
·  Ability to interpret and relate Quality standards for implementation and review
·  Ability to make sound decisions about scheduling and managing of priorities.
·  Flexibility in problem solving, providing direction and work hours to meet business objectives

Knowledge/Skills/Competencies

·  Strong oral and written communication skills.
·  Familiarity of computer-based systems
·  Ability to receive, interpret and provide basic information and materials involved with the day-to-day activities of performing the job.
·  Ability to read and understand technical quality documents is desirable

Experience in creation and revision of Standard Operating Procedures is desirable.

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Roche is an equal opportunity employer.
Quality, Quality > Quality Control

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.