Job description
Overview
Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA oversight activities. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers.
Responsibilities:
Responsible for final product Quality release/rejection and related processes.
Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA.
Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply.
Review and approve deviations, CAPAs, SOPs and Change Control related to manufacturing operations
Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).
Responsible for QA representation in Design Control Process for medical device products and combination products.
Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.
Manage the performance and development of 3-6 direct reports.
Support supplier and internal audits as necessary.
Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc.
Act as company’s representative during regulatory agencies and customer inspections.
Supports the investigation of product and related CAPAs.
Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
Support Statistical Trending of Manufacturing and Analytical Data.
Additional duties as assigned
Qualifications:
BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
Minimum 7 years’ experience working in 21CFR211 regulated environment required
Extensive knowledge of cGMPs and pharmaceutical and medical device manufacturing quality assurance.
Commercial drug manufacturing site QA head experience preferred
Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
Ability to solve complex problems and take proactive action
Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
Maintain professionalism, self-motivation, and enthusiasm.
Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing.
Must perform statistical analysis and capable of analyzing data to solve problems
Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
Experience with internal and external audits.
Experience reviewing manufacturing validation documents.
Preferred ASQ CQE and CQA Certifications.
Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.
Demonstrate ability to manage projects and variable workloads.
Excellent communication and coaching skills (verbal and written).
Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Qualifications
BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.
Commercial drug manufacturing site QA head experience preferred
Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
Ability to solve complex problems and take proactive action
Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
Maintain professionalism, self-motivation, and enthusiasm.
Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.
Must perform statistical analysis and capable of analyzing data to solve problems
Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines
Solid knowledge of all QC laboratory equipment and manufacturing equipment
Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
Experience with internal and external audits.
Experience reviewing manufacturing and QC validation documents.
Preferred ASQ CQE and CQA Certifications.
Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.
Demonstrate ability to manage projects and variable workloads.
Excellent communication and coaching skills (verbal and written).
Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA oversight activities. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers.
Responsibilities:
Responsible for final product Quality release/rejection and related processes.
Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA.
Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply.
Review and approve deviations, CAPAs, SOPs and Change Control related to manufacturing operations
Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).
Responsible for QA representation in Design Control Process for medical device products and combination products.
Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.
Manage the performance and development of 3-6 direct reports.
Support supplier and internal audits as necessary.
Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc.
Act as company’s representative during regulatory agencies and customer inspections.
Supports the investigation of product and related CAPAs.
Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
Support Statistical Trending of Manufacturing and Analytical Data.
Additional duties as assigned
Qualifications:
BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
Minimum 7 years’ experience working in 21CFR211 regulated environment required
Extensive knowledge of cGMPs and pharmaceutical and medical device manufacturing quality assurance.
Commercial drug manufacturing site QA head experience preferred
Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
Ability to solve complex problems and take proactive action
Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
Maintain professionalism, self-motivation, and enthusiasm.
Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing.
Must perform statistical analysis and capable of analyzing data to solve problems
Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
Experience with internal and external audits.
Experience reviewing manufacturing validation documents.
Preferred ASQ CQE and CQA Certifications.
Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.
Demonstrate ability to manage projects and variable workloads.
Excellent communication and coaching skills (verbal and written).
Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Qualifications
BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.
Commercial drug manufacturing site QA head experience preferred
Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
Ability to solve complex problems and take proactive action
Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
Maintain professionalism, self-motivation, and enthusiasm.
Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.
Must perform statistical analysis and capable of analyzing data to solve problems
Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines
Solid knowledge of all QC laboratory equipment and manufacturing equipment
Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
Experience with internal and external audits.
Experience reviewing manufacturing and QC validation documents.
Preferred ASQ CQE and CQA Certifications.
Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.
Demonstrate ability to manage projects and variable workloads.
Excellent communication and coaching skills (verbal and written).
Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).