Supervisor, Quality

For 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Today, Genentech manufactures and commercializes multiple biotechnology products that have helped patients suffering from serious diseases and conditions, including breast cancer, colorectal cancer, non-Hodgkin's lymphoma, lung cancer, rheumatoid arthritis, cystic fibrosis and allergic asthma. The company is the leading provider of anti-tumor therapeutics in the United States.

Our continued growth has created an opportunity for a Supervisor, Quality in our Oceanside, CA facility. Please take this opportunity to learn about Genentech, where the creativity and openness of an academic environment meet the rigorous dedication of industry-leading professionals focused on improving and extending people?s lives.

Responsibilities:
The candidate will schedule and supervise daily and weekly operations of the group, as well as distribute daily work assignments. He/she will coach, train and lead staff members and identify staff development needs in the areas of cGMP training, technical skills, safety, performance management and best practices. He/she will ensure that all operations are performed in compliance to SOPs and cGMP standards. The candidate will ensure that site-specific validation procedures and shared practices are being applied in accordance with the requirements set forth in the governing quality standards in partnership with Corporate Quality and Compliance. He/she will review and approve equipment qualification protocols and reports (including IQ, OQ, PQ and PV). He/she will review and approve lifecycle documentation (URS, FRS, DDS, FAT/SAT and Commissioning Protocols). The candidate will review and approve validation protocol deviations, as well as review and approve validation project plans and master plans. The incumbent will review documentation for equipment, utility and facility shutdown and startup. He/she will write and maintain QA SOPs as required. The candidate will provide validation assessments for change orders on direct impact systems and identify qualification requirements to ensure that the validated state is maintained and will assist or interact with regulatory agencies as necessary. The candidate will present and defend GMP documentation associated with quality practices, as well as supervise multiple direct reports. He/she will conduct annual employee performance reviews for all direct reports and provide each direct report with an understanding of job objectives, as well as discuss career development and coach employees as needed. He/she will act as a QA Validation Managerial designate.

Requirements:
A Bachelor?s (Life Science is preferred) with a minimum of five years of industry experience and two years of direct leadership experience is required. Knowledge of FDA requirements for GMP compliance is essential. The candidate must possess strong verbal and written communication skills. The ability to work under minimal supervision, act independently and exercise a moderate level of decision-making capability is required. The incumbent must have strong project management skills. Strong organizational skills, the ability to prioritize and expedite multiple tasks is essential.

Genentech offers one of the most comprehensive benefits packages in the industry. Join a company that attracts, retains and rewards talented and committed employees. Our culture emphasizes working hard, collaborating and sharing rewards. For immediate consideration, please visit www.gene.com/careers and reference Req. #1000014089. Genentech is an equal opportunity employer.