CSL Behring
Serves as the Maintenance, Engineering, Facilities, and Utilities (M2U) quality change control and investigation subject matter expert, while providing leadership for the team and oversight for training management.
This position is the liaison with site quality to assure alignment with site and global quality policies, change management, and compliance requirements.
Assures appropriate documentation is developed to manage change controls initiated by M2U to support project activities (capital and expenses).
Required to review and approve change control protocols and related documentation to assure proper quality attributes are included.
Responsibilities:
Serves as Quality and Compliance subject matter expert for M2U efforts.
Responsible for assuring that M2U activities are in agreement with Kankakee site, CSL Behring and industry standards regarding Quality Assurance, Change Management and Compliance requirements.
Oversees and manages a team of compliance engineers (change control and investigation owners) and training coordinator.
Interacts with Kankakee site quality group to assure project direction, work process changes, and proposed facility process designs are in agreement with quality requirements/ expectations.
Supports the M2U team in all Change Management activities.
Directs or participates in risk assessment development, as needed.
Manages the change management communication to the other departments/ stakeholders.
Assures that M2U team members and integrated service providers/ professional contractors are appropriately trained and that documentation and/or Plateau status is available per site requirements.
Supports/Participates in all FDA and global regulatory agency meetings and audits to support M2U audit readiness.
Helps develop strategy, schedule, and metrics to have oversight and management of change controls executed on time with minimal delay and impacts to startup and shutdown plans for manufacturing.
Collaborate with counterparts at Kankakee and other CSL sites to leverage change control best practices and drive consistency.
Oversight of experts/trainers and external training providers to design and deliver training programs.
Other job related duties as assigned
Qualifications:
Bachelor's degree in Engineering or Science preferred; in lieu of a Bachelor's degree, an Associates degree or local equivalent in a related fieldMinimum three years' experience working in a pharmaceutical or other FDA regulated industry, applying cGMPs as part of daily activities.
Minimum one year experience supervising two or more staff members.
Prior change control management and regulatory audit experience a plus.
In-depth knowledge of cGMPs.
Must demonstrate strong leadership qualities, excellent written and oral communication skills, ability to interpret and apply cGMP and quality principles in daily work, and strong computer/technical skills.
Ability to work in a team environment.
Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.
Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Learn more about CSL Behring.
We want CSL to reflect the world around usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!About the Company:
CSL Behring.
Estimated Salary: $20 to $28 per hour based on qualifications.
This position is the liaison with site quality to assure alignment with site and global quality policies, change management, and compliance requirements.
Assures appropriate documentation is developed to manage change controls initiated by M2U to support project activities (capital and expenses).
Required to review and approve change control protocols and related documentation to assure proper quality attributes are included.
Responsibilities:
Serves as Quality and Compliance subject matter expert for M2U efforts.
Responsible for assuring that M2U activities are in agreement with Kankakee site, CSL Behring and industry standards regarding Quality Assurance, Change Management and Compliance requirements.
Oversees and manages a team of compliance engineers (change control and investigation owners) and training coordinator.
Interacts with Kankakee site quality group to assure project direction, work process changes, and proposed facility process designs are in agreement with quality requirements/ expectations.
Supports the M2U team in all Change Management activities.
Directs or participates in risk assessment development, as needed.
Manages the change management communication to the other departments/ stakeholders.
Assures that M2U team members and integrated service providers/ professional contractors are appropriately trained and that documentation and/or Plateau status is available per site requirements.
Supports/Participates in all FDA and global regulatory agency meetings and audits to support M2U audit readiness.
Helps develop strategy, schedule, and metrics to have oversight and management of change controls executed on time with minimal delay and impacts to startup and shutdown plans for manufacturing.
Collaborate with counterparts at Kankakee and other CSL sites to leverage change control best practices and drive consistency.
Oversight of experts/trainers and external training providers to design and deliver training programs.
Other job related duties as assigned
Qualifications:
Bachelor's degree in Engineering or Science preferred; in lieu of a Bachelor's degree, an Associates degree or local equivalent in a related fieldMinimum three years' experience working in a pharmaceutical or other FDA regulated industry, applying cGMPs as part of daily activities.
Minimum one year experience supervising two or more staff members.
Prior change control management and regulatory audit experience a plus.
In-depth knowledge of cGMPs.
Must demonstrate strong leadership qualities, excellent written and oral communication skills, ability to interpret and apply cGMP and quality principles in daily work, and strong computer/technical skills.
Ability to work in a team environment.
Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.
Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Learn more about CSL Behring.
We want CSL to reflect the world around usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!About the Company:
CSL Behring.
Estimated Salary: $20 to $28 per hour based on qualifications.
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