For over 29 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, colon cancer, lung cancer, non-Hodgkin's lymphoma, cystic fibrosis, heart attack, stroke, growth hormone deficiency, psoriasis, and asthma. The company is the leading provider of anti-tumor therapeutics in the United States.
Our continued growth has created an opportunity for a Senior Manager 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:
This position is dedicated to leading the site GMP Technical Training Operations team, focusing on the effective utilization of group assets, attributes and business processes to deliver outstanding training and performance improvement solutions to identified customers. The candidate will sit within the HR/Training and PROP Portfolio Management department, which assists the gNIMO site to accomplish its goals and objectives. The Senior Manager will lead the GMP Technical Site Training management team (quality and mfg), ensuring the vision and mission of the group is aligned with customer needs. The candidate will develop and implement the strategic and tactical plans to meet defined training objectives and goals, as well as coach the management team to develop and implement viable operational processes that are robust and scalable. He/she will ensure training and performance improvement programs are effective and utilize constrained resources efficiently. The candidate will develop strong partnerships with key customers and stakeholders throughout the NIMO site and PROP and its Business Units, GMP Manufacturing, Quality Assurance, Quality Control, Corporate Compliance and Engineering, Maintenance and Calibration. He/she will manage the scope of operations and program priorities to ensure compliance under FDA and EU regulations, as well as identify alternative resources and advise, recommend and problem solve to meet the customer's needs. The candidate will oversee GMP training records and inspection preparation efforts, represent training as a quality system to regulatory agencies, as well as remain current in industry and sector best practices and approaches. He/she will provide input and oversight of the budget for GMP Training and manage instructional design programs and third party delivery of training programs. The candidate will assist in selecting and overseeing the work of training consultants, contractors and vendors, as well as serve as advocate and role model for integrating change into the organization. He/she will be responsible for maintaining an environment of high morale and commitment and modeling it through specific actions and behaviors.
Requirements:
A B.A./B.S. in a scientific or technical discipline is required and an advanced degree in an education or training-related area is preferred. The candidate must have a minimum of 8-10 years of experience in the biotech/pharmaceutical industry. He/she must be energetic, innovative, technically savvy and have strong quality orientation with a desire to deliver service excellence. The candidate should have 8-10 years of experience in designing and implementing training programs and initiatives from needs assessment through delivery. A proven track record of overseeing the implementation of complex cross-disciplinary, cross-department training initiatives and a minimum of 5 years management experience are required. The candidate must have the ability to manage a departmental budget and must work well in a collaborative team environment and communicate effectively with all levels of the organization. Strong influence and interpersonal skills, with the ability to work well with others in a proactive, positive and constructive manner is required. Excellent written and verbal communication skills and strong knowledge of manufacturing, cGMP's and compliance are 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. #1000009604. Genentech is an equal opportunity employer.
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