Role Purpose: Provide leadership to the Quality organization to ensure Teva’s quality systems and policies are in place and adhered to in order to comply with state, federal and foreign regulations. Also accountable for assuring the greatest level of departmental operational organization and efficiency and regular achievement of customer service objectives.
- Establish and implement site quality and regulatory policies to ensure compliance with federal, state, foreign and international regulations.
- Develop current and long range plans for the Quality organization to be consistent with overall business objectives, regulatory requirements, improvements in use of technology and development of people for appropriate succession planning and business continuity needs.
- Interface directly with regulatory agencies to address product quality and regulatory questions.
- Key quality site representative to regulatory agencies.
- Establish goals and priorities for the Quality organization to be in line with site and corporate objectives.
- Anticipate and plan for resource needs and determine appropriate staffing and budget needs to assure company’s short and long term goals are achieved.
- Provide a quality risk assessment to projects and processes to assure company operates within a compliant environment.
- Interface with Manufacturing, Engineering, R&D, Regulatory Affairs and Marketing to implement and maintain site strategic plans, company policies, regulatory and customer service requirements.
- Active participation as a member of Gödöllő’s Leadership Team.
- Head of Quality will be responsible for integrating quality activities from the Godollo facility with activities and functions associated with Regional and Global Quality initiatives.
Site Quality Division
- Bachelor Degree in Pharmacy preferred, Science or related fields considered.
- Master’s Degree in Pharmacy, Science, Business, Healthcare preferred; or an equivalent combination of education and experience related to Quality Assurance/Quality Control.
- At least 20 years pharmaceutical and manufacturing experience including recent senior Quality management responsibilities in sterile pharmaceutical manufacturing (parenteral).
- Excellent written and verbal communication skills. Thorough knowledge of cGMP’s, GCPs, and regulations related to applications and general pharmaceutical manufacturing practices (Hungarian regulations, FDA, EMA, etc.).
- Ability to lead a team and empower employees; driving decision making to the appropriate levels in the organization.
- English language knowledge (level of proficiency).