What are the responsibilities and job description for the QA Manager position at Chiesi Farmaceutici?
Department: Corporate Quality Operations
Job Type: Direct Employee
Team: Quality
Contract Type: Permanent
Location:
Cary, US
Purpose
The main purpose of this job is to manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, investigations, tracking and resolution in a timely manner.
Preferably he/she shall be able to make initial process improvements assessment
The responsibilities also include the evaluation of the performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements, in conjunction with the business partner. The role also includes quality management of the product lifecycle management in relation with All the corporate functions
Main Responsibilities
Accountable on CMOs oversight
Quality Operations activities management with key/critical CMOs
Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed.
Develop knowledge of the manufacturing line at key/critical contract organizations (CMOs) and provide technical support for the manufacture of product, in collaboration with SME
Collaborate actively with key/critical CMO to sustain without disruption the supply chain
Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with Chiesi expectations
Participate to technology transfer, scale-up or improvements projects through validation and on-site presence
Collect Key Process Indicators and Identify appropriate actions in collaboration with CMO up to successful implementation
Contribute to Regulatory inspection including needs of Chiesi presence, review of observations, responses and action plan follow-up
Prepare and Manage Quality management Review, Annual Product Review performance and Quality agreement
Support recall management.
Quality System
Identify and drive improvements/updates of the GMP documentation related to QE activities
Identify any compliance gap in Chiesi processes and identify appropriate stakeholder to fix the issue
Support local Quality system (change control, deviations, CAPAs, …) as required
Ensure adherence to serialization and data integrity requirements
Experience Required
Ability to travel international/domestic up to 70%
A minimum of 5 years of experience in pharmaceutical or biotechnology industries
Relevant experience in either manufacturing, development, quality or regulatory; Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies’ regulations is a plus);
Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams
Strong communication skills
Ability to work in an international matrix environment.
Good negotiation skills
Ability to clearly articulate complex situation into resolution by providing path forward to the upper management
Fluent English skills required, other languages a plus
Education
Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
Languages
Technical Skills
Soft Skills
Discover all our opportunities
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Job Type: Direct Employee
Team: Quality
Contract Type: Permanent
Location:
Cary, US
Purpose
The main purpose of this job is to manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, investigations, tracking and resolution in a timely manner.
Preferably he/she shall be able to make initial process improvements assessment
The responsibilities also include the evaluation of the performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements, in conjunction with the business partner. The role also includes quality management of the product lifecycle management in relation with All the corporate functions
Main Responsibilities
Accountable on CMOs oversight
Quality Operations activities management with key/critical CMOs
Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed.
Develop knowledge of the manufacturing line at key/critical contract organizations (CMOs) and provide technical support for the manufacture of product, in collaboration with SME
Collaborate actively with key/critical CMO to sustain without disruption the supply chain
Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with Chiesi expectations
Participate to technology transfer, scale-up or improvements projects through validation and on-site presence
Collect Key Process Indicators and Identify appropriate actions in collaboration with CMO up to successful implementation
Contribute to Regulatory inspection including needs of Chiesi presence, review of observations, responses and action plan follow-up
Prepare and Manage Quality management Review, Annual Product Review performance and Quality agreement
Support recall management.
Quality System
Identify and drive improvements/updates of the GMP documentation related to QE activities
Identify any compliance gap in Chiesi processes and identify appropriate stakeholder to fix the issue
Support local Quality system (change control, deviations, CAPAs, …) as required
Ensure adherence to serialization and data integrity requirements
Experience Required
Ability to travel international/domestic up to 70%
A minimum of 5 years of experience in pharmaceutical or biotechnology industries
Relevant experience in either manufacturing, development, quality or regulatory; Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies’ regulations is a plus);
Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams
Strong communication skills
Ability to work in an international matrix environment.
Good negotiation skills
Ability to clearly articulate complex situation into resolution by providing path forward to the upper management
Fluent English skills required, other languages a plus
Education
Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
Languages
Technical Skills
Soft Skills
Discover all our opportunities
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