Associate Manager Clinical QA
3.
7 1 hour ago Full Job Description Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.
If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc.
is a pharmaceutical company conducting business in more than 70 countries around the world.
We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.
Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.
For more information on Astellas, please visit our website at www.
astellas.
com.
This position is based in Northbrook, Illinois.
Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Responsible for the development and maintenance of excellence in Clinical QA (CQA) activities for Astellas sponsored programs.
This position works in partnership with Medical and Development functions (M&D) and other business units in support of global and local drug development, registration, and marketing for assigned projects across Therapeutic Area(s) (TAs) for all stages of drug development.
Reports to the Senior Director/Director/Associate Director, CQA and contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 years strategic plan.
Collaborates with relevant CRQA members and M&D for alignment with company-wide standards.
Ensures quality oversight of M&D processes and clinical trials (Phase I-IV) to maintain compliance with the international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations.
Responsible for managing, conducting and/or participating in regional/global audits and provides technical expertise to identify and resolve quality issues.
Essential Job
Responsibilities:
Conducts audits of clinical / non-clinical study sites, vendors / contractors, Astellas internal systems / procedures, and others as required.
Monitors progress of audit activities and reports status to management.
Compiles and distributes audit reports in a collaborative manner.
Updates related databases in a timely manner.
Generates status reports as required.
Identifies issues and reviews/approves corrective action plans proposed by the respective functional area.
Performs quality risk assessment as it pertains to GCP issues.
May represent CQA as a Global Quality Lead (GQL) on assigned project teams to provide direction regarding quality and compliance.
Provides support and consultation to other CQA functional areas as needed/ Participates in process improvements initiatives within CRQA and M&D functional areas, processes and systems.
Demonstrates the ability to assist in the management of assigned responsibilities or development programs.
Collaborates within the CRQA department and throughout the Astellas organization to identify and address regulatory compliance issue.
Assures GCP compliance with Quality Management System (QMS) Documents and regulatory agency requirements.
Utilizes established tools to track, trend and report quality metrics to management to assure that Astellas systems and procedures comply with Astellas and external regulatory authority requirements for compliance.
Provides support to the Clinical QA department and key stakeholders during regulatory agency inspections.
Support development of Data Analytics for QA.
Quantitative Dimensions:
Annual auditing of approximately 15-30 regional/global audits, depending on complexity Supports the development and management of inspection readiness plans for approximately 1/annum for regulatory agency inspections related to MAA / NDA submissions Responsible for supporting regulatory agency inspections of GCP activities and ensuring inspection readiness with an average of 2 inspections/annum Organizational Context:
Reports to the Senior Director/Director/Associate Director, CQA Peers include CRQA (associate) managers, and other global and regional M&D functional team members.
Collaborates directly with M&D stakeholders to achieve common objectives
Qualifications:
Required Bachelor's degree Minimum of 2 years in pharmaceutical, biotechnology, or related industry Minimum of 1 year project management/clinical monitoring experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills General knowledge and understanding of GCP requirements for both marketed and investigational products Effective oral and written communication and presentation skills in English and/or Japanese Understanding of CRQA processes Proficiency in Microsoft Office Domestic and international travel at 10-25% as required Preferred Advanced degree in related disciplines Preferred location for this position is Northbrook (IL) - United States, Leiden - The Netherlands, Tokyo - Japan
Benefits:
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Referral bonus program JB-LI1 Category Clinical QA Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans.
Estimated Salary: $20 to $28 per hour based on qualifications.
7 1 hour ago Full Job Description Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.
If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc.
is a pharmaceutical company conducting business in more than 70 countries around the world.
We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.
Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.
For more information on Astellas, please visit our website at www.
astellas.
com.
This position is based in Northbrook, Illinois.
Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Responsible for the development and maintenance of excellence in Clinical QA (CQA) activities for Astellas sponsored programs.
This position works in partnership with Medical and Development functions (M&D) and other business units in support of global and local drug development, registration, and marketing for assigned projects across Therapeutic Area(s) (TAs) for all stages of drug development.
Reports to the Senior Director/Director/Associate Director, CQA and contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 years strategic plan.
Collaborates with relevant CRQA members and M&D for alignment with company-wide standards.
Ensures quality oversight of M&D processes and clinical trials (Phase I-IV) to maintain compliance with the international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations.
Responsible for managing, conducting and/or participating in regional/global audits and provides technical expertise to identify and resolve quality issues.
Essential Job
Responsibilities:
Conducts audits of clinical / non-clinical study sites, vendors / contractors, Astellas internal systems / procedures, and others as required.
Monitors progress of audit activities and reports status to management.
Compiles and distributes audit reports in a collaborative manner.
Updates related databases in a timely manner.
Generates status reports as required.
Identifies issues and reviews/approves corrective action plans proposed by the respective functional area.
Performs quality risk assessment as it pertains to GCP issues.
May represent CQA as a Global Quality Lead (GQL) on assigned project teams to provide direction regarding quality and compliance.
Provides support and consultation to other CQA functional areas as needed/ Participates in process improvements initiatives within CRQA and M&D functional areas, processes and systems.
Demonstrates the ability to assist in the management of assigned responsibilities or development programs.
Collaborates within the CRQA department and throughout the Astellas organization to identify and address regulatory compliance issue.
Assures GCP compliance with Quality Management System (QMS) Documents and regulatory agency requirements.
Utilizes established tools to track, trend and report quality metrics to management to assure that Astellas systems and procedures comply with Astellas and external regulatory authority requirements for compliance.
Provides support to the Clinical QA department and key stakeholders during regulatory agency inspections.
Support development of Data Analytics for QA.
Quantitative Dimensions:
Annual auditing of approximately 15-30 regional/global audits, depending on complexity Supports the development and management of inspection readiness plans for approximately 1/annum for regulatory agency inspections related to MAA / NDA submissions Responsible for supporting regulatory agency inspections of GCP activities and ensuring inspection readiness with an average of 2 inspections/annum Organizational Context:
Reports to the Senior Director/Director/Associate Director, CQA Peers include CRQA (associate) managers, and other global and regional M&D functional team members.
Collaborates directly with M&D stakeholders to achieve common objectives
Qualifications:
Required Bachelor's degree Minimum of 2 years in pharmaceutical, biotechnology, or related industry Minimum of 1 year project management/clinical monitoring experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills General knowledge and understanding of GCP requirements for both marketed and investigational products Effective oral and written communication and presentation skills in English and/or Japanese Understanding of CRQA processes Proficiency in Microsoft Office Domestic and international travel at 10-25% as required Preferred Advanced degree in related disciplines Preferred location for this position is Northbrook (IL) - United States, Leiden - The Netherlands, Tokyo - Japan
Benefits:
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Referral bonus program JB-LI1 Category Clinical QA Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans.
Estimated Salary: $20 to $28 per hour based on qualifications.
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