Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.
We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!
This position is responsible for the daily QA oversight of LSNE's commercial manufacturing plant. The role includes review and final disposition of batch records, releasing finished product and raw materials lots, reviewing / approving investigations and change controls, interacting with Clients concerning site specific quality issues, approving site CGMP documents, contributing to CGMP reports, and managing QA site staff as necessary to achieve these tasks. The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems across all LSNE GMP locations.
Leading Quality Assurance oversight of product release, batch record execution, batch record review, approval of production deviations, change controls, compliance, and investigations.
Working with project teams to represent the Quality organization, conducting risk assessments and introducing best practices into the Quality Management Systems across all LSNE business units.
Leading the commercial quality unit to include manufacturing record review, raw data review, investigation review and final release of drug product.
Leading QA personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews and guiding personnel in longer-term development. Overseeing Quality Risk Management activities.
Providing QA oversight of QC Chemistry and Microbiology testing in support of site batch manufacturing.
Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance.
Providing QA oversight/leadership during FDA and EMA site inspections.
Demonstrates substantial knowledge of industry best practices and trends.
Other tasks as assigned by management
EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE
10+ years Pharmaceutical or Biotechnology industry experience. Prior experience in leading a commercial, aseptic drug product quality assurance team highly preferred
5+ years previous QA management/leadership experience
BS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. Advanced level degree preferred
Quality leadership experience working on cross-functional teams to harmonize operational and compliance processes.
Quality Operations leadership within Quality Systems, Quality Compliance, Document Control, Quality Engineering, Validation or Technical Operations capacities.
Prior experience in a CMO or dealing with CMOs preferred
Medical Device experience a plus
Demonstrates excellent verbal, written, and interpersonal communication skills.
Demonstrated ability to perform in a fast paced environment
In depth knowledge of aseptic manufacturing practices and current industry trends for visual inspection of injectable products.
Prior experience hosting regulatory inspections, leading inspection readiness activities, and leading Pre-Approval Inspections (PAI) preferred.
Must be able to walk or move about between locations
Must be able to sit or stand for prolonged periods of time.
COMMUNICATIONS & CONTACTS
Works closely with internal quality assurance teams.
Interacts with all departmental staff and other departments at all levels.
Must be comfortable presenting technical and complex issues clearly to all levels of management as well as client representatives.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Lsne Contract Manufacturing