Sr Manager QA Compliance
Vor 7 Tagen
The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
The state-of-the-art multi-purpose manufacturing facility is designed for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.
The job
The Sr. Manager QA Compliance & GMP Readiness is part of the Quality Management team at our new Lengnau facility. This person’s core responsibility lies in the lead and governance of inspection management, GMP-operational readiness and support of main QMS.
During ramp up of the facility, the role plays a key part in conceptual evaluation and implementation of main Quality processes and additionally provide QA support and mentorship to related functional departments.
This role will provide oversight and supervision of the compliance activities within Lengnau site.
This role will interact with varying levels of staff within the organization as well as with customers and auditors. Also, this role will be responsible for making decisions regarding compliance of processes that will impact the product. In addition, will coordinate QA activities and programs such as quality agreements, metrics, auditing, record review, final product functions, complaints, document management, and oversight of quality systems and/or investigations within QA.
What will you do?
- Position Responsibilities & Accountabilities/Technical Responsibilities:
- Develop and implement concepts for GMP readiness of the site (as part of Operational Readiness).
- Lead Implementation of inspection readiness of the site including development and implementation of inspection related processes in accordance to global procedures.
- Collaborate with and lead cross-functional teams on quality-related projects.
- Coordinate and participate in global quality initiatives (e.g. Procedure harmonization, guideline gap assessments).
- Prepare company regulatory submissions (e.g. site master files, drug master files) in collaboration with our partner site Allschwil.
- Operate successfully in a matrix organization and own Quality matters across Functions, Departments and Suppliers in order to resolve issues and improve performance.
- Coordinates critical issue process including quality escalations within the matrix organization.
- Implement, support and maintain cGMP compliant Quality Management Systems through continual improvement.
- Constantly strive to enhance efficiency in procedures and processes without a compromise in quality. Identify and implement opportunities for improvement across the operational facility.
Quality- Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management.
- Actively contributes to continuous quality improvement initiatives and deviation reporting and follow-up.
EHSS- Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
- Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.
Values & Behaviour- Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
- Takes personal accountability for their presence, performance, and productivity for the achievements of defined objectives.
- Develop a Quality culture with creative events
- Thinks and acts with a customer-centric mindset.
- Is intellectually curious and embr
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