novartis group companies
senior quality assurance engineer leadPosted
1 week 3 days ago
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Job Description
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Job Description Summary
Location: Carlsbad, California (on-site)
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with Manufacturing and Quality experience to join the team at our new Carlsbad site.
As the Senior Quality Assurance Engineer Lead, you will be responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Carlsbad RLT manufacturing site.
Job Description
Key Responsibilities:
Ensure Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that the facility is:
Compliant with all Novartis QMS and appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing.
Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.
Capable to meet intended design goals of output volume, turnaround time and operating and product costs.
Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).
Provide oversight of the Computerized System Validation Lifecycle efforts to ensure compliance with 21 CFR Part 11, EudraLex Annex 11, and applicable FDA/EMA Guidance's on electronic data integrity.
Participate in development and implementation of validation strategies, policies, and other documentation for CSV systems and IT applications. Provide Quality oversight, review, and approve Validation Documentation including but not limited to: Validation Master Plan, User Requirements, Functional Requirements, Installation Qualification, Operational Qualification, Performance Qualification, Trace Matrix, Validation Summary Reports, and Change Controls.
Support cross-functional team risk assessments to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration). Review and approve change controls, SOPs, Deviations, and CAPAs associated with qualification/validation execution to ensure effectiveness of actions.
Ensure that vendor assessments, audits and quality agreements (if required) of suppliers of GxP computer software are in place.
Lead and support internal self-inspections.
Ensure all quality personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations.
Essential Requirements
B.S. degree and 6+ years of experience in a GxP pharmaceutical manufacturing operations, including at least 2+ years of experience in a quality assurance role.
Strong knowledge and application of the CFR's and cGMP's and have been involved in regulatory inspections.
Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. Experience leading internal audits, identify findings, drive resolution and provide closure report is desired.
Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
Experience with deviations, CAPAs, and Change Controls.
Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
Experience leading people. Excellent oral and written communication skills with strong technical writing experience required.
Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
Desirable Requirements
B.S. in Engineering, Chemistry or Biochemistry.
Sterile manufacturing experience preferred.
Salary Range
$112,800.00 - $169,200.00
Skills Desired
Continuous Learning
Dealing With Ambiguity
Employee Performance Evaluations
Gmp Procedures
People Management
Qa (Quality Assurance)
Quality Control (Qc) Testing
Quality Standards
Self-Awareness
Technological Expertise
Technological Intelligence
#J-18808-Ljbffr
Location: Carlsbad, California (on-site)
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with Manufacturing and Quality experience to join the team at our new Carlsbad site.
As the Senior Quality Assurance Engineer Lead, you will be responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Carlsbad RLT manufacturing site.
Job Description
Key Responsibilities:
Ensure Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that the facility is:
Compliant with all Novartis QMS and appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing.
Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.
Capable to meet intended design goals of output volume, turnaround time and operating and product costs.
Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).
Provide oversight of the Computerized System Validation Lifecycle efforts to ensure compliance with 21 CFR Part 11, EudraLex Annex 11, and applicable FDA/EMA Guidance's on electronic data integrity.
Participate in development and implementation of validation strategies, policies, and other documentation for CSV systems and IT applications. Provide Quality oversight, review, and approve Validation Documentation including but not limited to: Validation Master Plan, User Requirements, Functional Requirements, Installation Qualification, Operational Qualification, Performance Qualification, Trace Matrix, Validation Summary Reports, and Change Controls.
Support cross-functional team risk assessments to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration). Review and approve change controls, SOPs, Deviations, and CAPAs associated with qualification/validation execution to ensure effectiveness of actions.
Ensure that vendor assessments, audits and quality agreements (if required) of suppliers of GxP computer software are in place.
Lead and support internal self-inspections.
Ensure all quality personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations.
Essential Requirements
B.S. degree and 6+ years of experience in a GxP pharmaceutical manufacturing operations, including at least 2+ years of experience in a quality assurance role.
Strong knowledge and application of the CFR's and cGMP's and have been involved in regulatory inspections.
Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. Experience leading internal audits, identify findings, drive resolution and provide closure report is desired.
Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
Experience with deviations, CAPAs, and Change Controls.
Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
Experience leading people. Excellent oral and written communication skills with strong technical writing experience required.
Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
Desirable Requirements
B.S. in Engineering, Chemistry or Biochemistry.
Sterile manufacturing experience preferred.
Salary Range
$112,800.00 - $169,200.00
Skills Desired
Continuous Learning
Dealing With Ambiguity
Employee Performance Evaluations
Gmp Procedures
People Management
Qa (Quality Assurance)
Quality Control (Qc) Testing
Quality Standards
Self-Awareness
Technological Expertise
Technological Intelligence
#J-18808-Ljbffr
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