Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Basel

Description

At Roche, we believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.
Quality is a competitive advantage for Genentech/Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Our philosophy – which permeates across the entire Pharmaceutical Technical Operations organization – is that quality is every patient’s right and every employee’s responsibility.
The Quality Site Head is accountable for the quality of the products manufactured at the site and ensures compliance with valid specifications and cGMP requirements. The Quality Site Head is accountable for the quality of the clinical, commercial and launch products and ensures compliance with valid specifications and cGMP requirements.
The focus of Basel Biotech is Drug Substance manufacturing in two facilities, including the to-be-licensed small production scale line comprised of single-use technologies. The Quality Site Head is a member of the Quality MU Leadership Team, an extended PTQ LT member, a member of the Site Leadership Team and partner to the Site Head.
Key responsibilities
Quality Management:
Accountable to ensure that manufactured product meets Health Authority regulations, Company standards and expectations.
Develop strategic goals and objectives to support the monitoring, review, testing and timely reporting on the quality of Roche/Genentech products.
Provide leadership and guidance to staff directing Quality functions, manage performance and development of direct reports to ensure achievement of organizational and departmental goals and a productive environment
Proactively prepare for and manage Health Authority inspections by ensuring the site is operating in an “inspection ready” manner at all times. Prepare adequate and timely responses to any inspection observations and implement appropriate and thorough corrections, as necessary.
Maintain an effective Quality governance and continually improve the governance to meet business and compliance needs.
Perform other tasks as requested by Executive Management to support Quality oversight activities.
Ensure that the in-process analytics and quality control comply with regulatory requirements.
Ensure that the quality of the source materials for the production comply with the product-specific and legal requirements
Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.
Leadership:
Develop and communicate organizational strategies, which ensure the GMP compliance of the site, continuous improvements and achievement of long term goals.
Lead, coach, and guide the organization. Manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth.
Build a strong pipeline of talent and robust succession plans for key positions.
Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.
Be the champion and advocate for Engrained Quality at the Site.
Build a culture of continuous improvement and model lean leadership principles.
Collaboration:
Partner with the Site Head on strategic business direction and decisions.
Build and maintain strong partnerships with other site and network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationship.
Financial:
Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources.
Technical Duties/Responsibilities:
Serve as final decision–maker and spokesperson for the Quality Unit. This role is the decision maker for the Quality Unit at the site including heading the Quality Review Board.
Establish and manage the Quality Unit organizational, managerial and accountability structures.
Direct and provide guidance on all Quality matters, ensure and manage interfaces to other relevant Quality Units.
Define the strategies needed to reach the site and network goals. Develop and communicate goals and metrics to ensure achievement of

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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