Sr Associate III, Quality Assurance

The QA Operations Sr. Associate III assures all operations meet or exceed cGMP regulations, ensuring high level of quality of Cell bank and Bulk Drug Substance. This position is responsible for providing Quality Assurance input and oversight for upstream successful life cycle development and production in compliance with cGMP, regulatory requirements and Quality Management System. The main responsibility is accomplished by deep knowledge in cell culture and fermentation processes and the effort to continually improve the Quality and Environmental Management Systems and our systems, products and processes. This position will contribute to lead, motivate and develop the Quality Operations team and assure knowledge and experience with respect to cGMP requirements. This role is expected to be cross-functional between the Luterbach Quality and site organization with primary interface with Manufacturing, and will also work closely with other business groups as, but not limited to, quality systems, quality engineering, quality control, Global QM/RA, manufacturing science, and supply chain.

As such, the position is expected to have outstanding level knowledge in upstream operations and business processes within a cGMP Biotech environment as well experiences on manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation.

B. Principal Accountabilities

Accountability Descriptions

1 Review and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).

2 Support/train cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.

3 Manage the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.

4 Act on internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs.

5 Revise and approve Standard Operating Procedures as needed.

6 Ensure the continuous alignments with the quality and change control management systems

7 Manage review metrics for identification of negative trends

C. Minimum Education Requirements

Masters in Science / Engineering in Life Science or Technical discipline

Other Posting Information –

• This position will require frequent international travel during the first two years of employment (up to 20% at times), periodically thereafter.
• Dual Language preferred with a preference for German and/or English.
• Prior experience with facility construction and start-up strongly preferred.
• Must have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.
• Demonstrated and proved ability to work autonomously and to lead project teams in a matrix organization.
• Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
• Demonstrated and proved problem solving skills
• Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
• Candidates with experience in drug substance (or API) and drug product is mandatory.
• Ability to work in shift model including during the weekend
• Good experience in participating in pharmaceutical technology transfer team
• Good experience in the qualification of facilities, utilities, equipment and processes
• Experience in preparing and coordinating regulatory inspections