Senior Manager Quality Assurance – Parenteral Pilot Plant & New Product Introduction-00000STX
Description
Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a
Senior Manager Quality Assurance –
Parenteral Pilot Plant & New Product Introduction.
We manufacture high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
POSITION SUMMARY:
The function holder is responsible for the leadership and development of team to support the timely and compliant launch of new products and to provide Quality oversight of the Analytical Development Labs and the Parenteral Pilot Plant which manufactures a range of parenteral dosage forms for clinical phase 1, 2 and 3 trials and small scale commercial product.
PRINCIPAL RESPONSIBILITIES:
- Responsible for the oversight of all quality activities associated with the Parenteral Pilot Plant product portfolio. This will include batch assessment and release, deviation and CAPA management, inspection readiness, product quality performance management, trend reporting and compliance to Quality Management Systems.
- Provide active quality and compliance support and leadership to the site operational and quality units.
- Driving a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
- Management of organizational performance and succession planning through training and development.
- Maintains a culture of high employee engagement, collaboration, flexibility and competitiveness by increasing business and scientific acumen, industry knowledge and executional skills.
- Quality representative in New Product Introduction teams.
Qualifications
PROFILE:
- BA or BS degree in Life Sciences, Pharmacy or Engineering
- Minimum 5 years in a leadership role within a global supply chain in a parenteral Quality Operations leadership role or a Parenteral Manufacturing role ideally with New Production Introduction experience or
- Strong understanding of parenteral manufacturing and knowledge of global regulatory requirements
- Experienced in leading regulatory inspections
- Demonstrated leadership and people development skills in either Quality or Parenteral Manufacturing Operations
- Ability to operate in a global matrix organization with multiple stakeholders
- Strong decision making and problem solving competencies
- Excellent communication skills, verbal and written in both English and German
- Flexible, motivated and innovative team player
- Working knowledge of risk management tools
- Ability to influence and negotiate across the organization at all levels.
We are offering you a challenge in a dynamic, international environment with attractive terms and career opportunities.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen
Organization: Cilag AG (8562)
Job Function: Quality
Description
Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a
Senior Manager Quality Assurance –
Parenteral Pilot Plant & New Product Introduction.
We manufacture high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
POSITION SUMMARY:
The function holder is responsible for the leadership and development of team to support the timely and compliant launch of new products and to provide Quality oversight of the Analytical Development Labs and the Parenteral Pilot Plant which manufactures a range of parenteral dosage forms for clinical phase 1, 2 and 3 trials and small scale commercial product.
PRINCIPAL RESPONSIBILITIES:
- Responsible for the oversight of all quality activities associated with the Parenteral Pilot Plant product portfolio. This will include batch assessment and release, deviation and CAPA management, inspection readiness, product quality performance management, trend reporting and compliance to Quality Management Systems.
- Provide active quality and compliance support and leadership to the site operational and quality units.
- Driving a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
- Management of organizational performance and succession planning through training and development.
- Maintains a culture of high employee engagement, collaboration, flexibility and competitiveness by increasing business and scientific acumen, industry knowledge and executional skills.
- Quality representative in New Product Introduction teams.
Qualifications
PROFILE:
- BA or BS degree in Life Sciences, Pharmacy or Engineering
- Minimum 5 years in a leadership role within a global supply chain in a parenteral Quality Operations leadership role or a Parenteral Manufacturing role ideally with New Production Introduction experience or
- Strong understanding of parenteral manufacturing and knowledge of global regulatory requirements
- Experienced in leading regulatory inspections
- Demonstrated leadership and people development skills in either Quality or Parenteral Manufacturing Operations
- Ability to operate in a global matrix organization with multiple stakeholders
- Strong decision making and problem solving competencies
- Excellent communication skills, verbal and written in both English and German
- Flexible, motivated and innovative team player
- Working knowledge of risk management tools
- Ability to influence and negotiate across the organization at all levels.
We are offering you a challenge in a dynamic, international environment with attractive terms and career opportunities.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen
Organization: Cilag AG (8562)
Job Function: Quality