SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Cambridgeshire United Kingdom.

The Company

Our client is a Biotech company in the Cambridge area

Role Description

The Head Quality Assurance works with contract manufacturers to ensure manufacturing deviations are investigated, root cause analysis is complete and CAPAs are closed in a timely manner. Provide quality requirements and standards to all Operations Teams and product development teams, represent voice of Quality and Compliance in all product and process related decisions. Lead and organise assessments of current product licenses and implements the TRD (eCTD) system.
Review and approve all regulatory submissions to improve and assure regulatory compliance. Oversee external audits (regulatory authorities & customer audits)

Responsibilities

- Negotiates QA agreements with external suppliers and resolves disputes.
- Provides effective leadership
- Development and implementing objectives and business strategies
- Defining headcount, hiring/selecting key personnel and motivating members of the functional area
- Challenging employees to develop as leaders while serving as a role model and mentor
- Assisting with Performance Calibration/Talent Pool Management/Succession Planning
- Individual goal setting/performance reviews; training and development
- Supporting workforce diversity, quality and safety and supporting supervisors/managers in management of their employees/department which support achievement of individual/department/business objectives

Requirements

- 10 years of leadership experience in a Quality environment in manufacturing or development of pharmaceutical or biotech products and 7 years’ experience in international biopharmaceutical/pharmaceutical industry or an equivalent combination of education and experience
- Excellent knowledge of Quality Management processes as well as of biopharmaceutical manufacturing/CMC
- Excellent knowledge of EMA and FDA requirements in cGMP
- Excellent understanding of manufacturing process technology in the Biotech area
- Good project management skills, experienced in working with international, interdisciplinary teams (internal and external matrix organisations)
- Significant experience managing and providing oversight to Contract Manufacturers who supply product intermediates and/or finished goods
- Strong interpersonal skills, leadership and motivation of employees
- Ability to lead organisational change and build teams
- Strong analytical and conceptual thinking, target oriented
- Strong decision making skills
- Strong quality and cost awareness, negotiation skills

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.