Senior Manager Quality Assurance Small Molecules

My client, a world leading pharmaceutical manufacturer, are looking for a Senior Manager Quality Assurance Small Molecules to join their team on a permanent basis. The function holder is responsible for the Quality Oversight of Small Molecule manufacturing (API and Drug Product), and reports directly into the Senior Director of Quality. 

RESPONSIBILITIES:

• Drive a culture of proactive quality and continuous improvement to ensure compliance with, regulatory requirements and expectations.
• Functions as the link with the Small Molecules Quality platform of as a member of the Small Molecules Quality platform leadership team
• Follow up on management indicators and results.
• Ensure management and closure of non-conformance records, change control records and corrective / preventive actions.
• Guide, train, evaluate and develop the personnel in charge.
• Provide guidance and direction on Quality investigations to different areas.
• Escalation Lead for significant Quality investigations
• Provide information analysis and guidance to site and management in projects with GxP impact, ensuring adequate communication of needs and quality status & compliance to all areas affected.
• Act as an expert in quality and compliance in the inter-functional groups of the company.
• Ensure that the Business unit is ready to receive audits or GxP inspections.
• Lead audits and GxP inspections as e.g. Swissmedic or other HA inspections
• Evaluate the results of management reviews, audits, etc., and govern the implementation of corrective actions.
• Evaluate quality performance indicators and lead the implementation of the actions required for continuous improvement.
• Prepare and manage the budget of the area ensuring good control and use of resources.
• Provide guidance and training to quality personnel according to the company's organizational and policy objectives.
• Ensure alignment and benchmarking with other manufacturing sites

Qualifications
•    A minimum of a Bachelor’s degree is required with a major or concentration in one of the following: Chemistry, Pharmacy, Biochemistry, Engineering, or a similar technical/scientific degree. A Master’s degree or advanced is desirable.
•    Minimum 5 years in a leadership role within an API or Drug Product supply chain in Operations or Quality Operations.
•    Strong understanding of manufacturing, analytics, quality, compliance and knowledge of local & global regulatory requirements
•    Experienced in leading and coordinating regulatory inspections and customer audits
•    Ability to operate in a global matrix organization with multiple stakeholders
•    Fluent in English, German desirable
•    Flexible, motivated and solution oriented team player
•    In-depth knowledge in GMP standards, policies and procedures
•    Strong decision making and problem solving competencies
•    Knowledge of administration and personnel management.
•    Sound knowledge about implementation and optimization of quality systems and processes
•    Knowledge of statistics and process excellence tools
•    Ability to influence and negotiate across the organization at all levels.
•    Leadership imperatives