What are the responsibilities and job description for the (CW) Technical Manager, QA (Contract) position at BioSpace?
:
Responsible for owning and continuously improving one or more global Supplier Quality Management
(SQM) processes at BioMarin. As Business Process Owner (BPO), they are accountable
for the overall efficiency/effectiveness of the Supplier Change Notification (SCN)
process and Approved Supplier List (ASL) process at BioMarin. The Technical Manager
will be accountable for developing, executing associated processes, programs, and
initiatives to ensure overall supplier performance for GMP Material Suppliers to support
BioMarin’s Drug Substance and Drug Product manufacturing. They will contribute to the
implementation of a risk-based approach to the management of SCNs and lead efforts for
periodic review and updates. They will establish the governance structure and controls to
ensure the SCN and ASL processes are consistently applied across the supply base,
ensure the health of the SQM process is continuously evaluated, and drive continuous
improvement.
Cross functional collaboration with external and internal partners and stakeholders across
different sites and functions is key for success in this role. This includes collaboration
with Supply Chain, Compliance, Global Sourcing and Procurement (GSP), Global
Manufacturing Sciences And Technology (GMSAT), And Other Site Functions.
This position requires knowledge and experience with supplier management processes.
The person must possess technical expertise and business acumen in the areas of
responsibility.
Responsibilities
▪ Lead Quality-related reviews, cross-functional process teams, serving as a subject
matter expert for Supplier Change Notifications.
▪ Lead all quality aspects for the management of BioMarin’s Approved Supplier
List.
▪ Establish process to monitor SCNs through key performance indicators (KPIs),
trend analysis, and regular reviews, identifying and leading opportunities for
improvement.
▪ Serve as the Business Process Owner for SCN and ASL process(es), proactively
monitoring and maintaining the health of the process and subprocesses, driving
continuous improvement efforts, and sustaining compliance with current and
evolving global health authority requirements and regulations.
▪ Review and approve Supplier Change Notifications in the QMS.
▪ Make decisions and act with authority to carry out actions as applicable.
▪ Collaborate with external/internal global and site stakeholders to identify, define,
and implement opportunities for improved SCN process workflows, while
aligning the process with organizational goals and strategies. Promote knowledge
sharing and the best practices.
▪ Develop, implement, and communicate quality policies and procedures to ensure
consistency across the network and alignment with global processes.
▪ Support implementation of program enhancements to SCN and ASL processes.
▪ Provide SME support to site inspections, global inspections, and related
observation responses.
EDUCATION
▪ BA/BS in life sciences or related field
Experience
▪ 6 years of experience with Biotechnology, Pharmaceutical, Medical Device or
other highly regulated industry
▪ Knowledge and experience in GMP and GDP global regulations, principles,
concepts, practices, and standards.
▪ Prior experience and knowledge in Supplier Quality, Compliance, or a
combination of experience such as Manufacturing, Quality, and Regulatory
Required. Knowledge In International Regulatory Landscape Preferred.
▪ Demonstrated ability to work effectively in a matrix environment and drive
results through “influence” as well as direct management.
▪ Organizational and management skills, with ability to effectively plan, schedule,
execute, and track complex projects.
▪ Excellent interpersonal and communication skills and ability to influence diverse
stakeholders and drive accountability and decision-making cross functionally.
▪ Ability to present data and defend approaches in front of management and
inspectors.
▪ Ability to partner with other functional group to achieve business objectives.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Responsible for owning and continuously improving one or more global Supplier Quality Management
(SQM) processes at BioMarin. As Business Process Owner (BPO), they are accountable
for the overall efficiency/effectiveness of the Supplier Change Notification (SCN)
process and Approved Supplier List (ASL) process at BioMarin. The Technical Manager
will be accountable for developing, executing associated processes, programs, and
initiatives to ensure overall supplier performance for GMP Material Suppliers to support
BioMarin’s Drug Substance and Drug Product manufacturing. They will contribute to the
implementation of a risk-based approach to the management of SCNs and lead efforts for
periodic review and updates. They will establish the governance structure and controls to
ensure the SCN and ASL processes are consistently applied across the supply base,
ensure the health of the SQM process is continuously evaluated, and drive continuous
improvement.
Cross functional collaboration with external and internal partners and stakeholders across
different sites and functions is key for success in this role. This includes collaboration
with Supply Chain, Compliance, Global Sourcing and Procurement (GSP), Global
Manufacturing Sciences And Technology (GMSAT), And Other Site Functions.
This position requires knowledge and experience with supplier management processes.
The person must possess technical expertise and business acumen in the areas of
responsibility.
Responsibilities
▪ Lead Quality-related reviews, cross-functional process teams, serving as a subject
matter expert for Supplier Change Notifications.
▪ Lead all quality aspects for the management of BioMarin’s Approved Supplier
List.
▪ Establish process to monitor SCNs through key performance indicators (KPIs),
trend analysis, and regular reviews, identifying and leading opportunities for
improvement.
▪ Serve as the Business Process Owner for SCN and ASL process(es), proactively
monitoring and maintaining the health of the process and subprocesses, driving
continuous improvement efforts, and sustaining compliance with current and
evolving global health authority requirements and regulations.
▪ Review and approve Supplier Change Notifications in the QMS.
▪ Make decisions and act with authority to carry out actions as applicable.
▪ Collaborate with external/internal global and site stakeholders to identify, define,
and implement opportunities for improved SCN process workflows, while
aligning the process with organizational goals and strategies. Promote knowledge
sharing and the best practices.
▪ Develop, implement, and communicate quality policies and procedures to ensure
consistency across the network and alignment with global processes.
▪ Support implementation of program enhancements to SCN and ASL processes.
▪ Provide SME support to site inspections, global inspections, and related
observation responses.
EDUCATION
▪ BA/BS in life sciences or related field
Experience
▪ 6 years of experience with Biotechnology, Pharmaceutical, Medical Device or
other highly regulated industry
▪ Knowledge and experience in GMP and GDP global regulations, principles,
concepts, practices, and standards.
▪ Prior experience and knowledge in Supplier Quality, Compliance, or a
combination of experience such as Manufacturing, Quality, and Regulatory
Required. Knowledge In International Regulatory Landscape Preferred.
▪ Demonstrated ability to work effectively in a matrix environment and drive
results through “influence” as well as direct management.
▪ Organizational and management skills, with ability to effectively plan, schedule,
execute, and track complex projects.
▪ Excellent interpersonal and communication skills and ability to influence diverse
stakeholders and drive accountability and decision-making cross functionally.
▪ Ability to present data and defend approaches in front of management and
inspectors.
▪ Ability to partner with other functional group to achieve business objectives.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.