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!

JOB SUMMARY:

The Compliance Manager, Quality Control is responsible to ensure the department's overall inspection readiness by working closely with department leadership, and other QC team members by ensuring consistent adherence to compliance requirements, identifying gaps and addressing them to drive consistent application of GMP standards.

The incumbent monitors the regulatory compliance environment for emerging trends and changes and assessing their potential impact to the business.

JOB DUTIES:

• Represent the Quality Control organization during client audits and regulatory authority inspections
• Lead the Quality Control organization preparing audit responses and ensure responses are actions are implemented within the given time frame.
• Support the Internal Audit Programs to ensure the QC Department is in a state of compliance
• Responsible for QC audit preparations, to include but not limited to: log book review, training record review, SOP and data review. Assist QC managers conducting internal Departmental audits.
• Collaborates cross-functionally with stakeholders to maintain product distribution processes are aligned to the needs of LSNE and its clients, ensuring best practice, compliance and alignment with business needs
• Routinely checks and confirms that potential gaps are identified and addressed through scheduling and completion of QC quality system related activities.
• Revise(s) technical documentation (e.g. SOPs, policies, forms, etc.) as required.
• Works closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements across all LSNE sites · Uses industry standards in the development of company's concepts and principles
• Supports the development and management of QC department metrics to optimize performance, productivity and effective resource planning

PROFESSIONAL SKILLS:

• Must have strong attention to detail as well as ability to work in a cross-functional team environment
• Excellent organizational skills to balance work and prioritize tasks and assignments
• Multi-disciplinary knowledge of Quality Control
• Strong capability for logical, analytical thinking
• Problem analysis and resolution skills required
• Proficient in Microsoft Office, Excel, and PowerPoint.
• Excellent communication skills, oral and written

EXPERIENCE:

• 10 years' experience in a cGMP organization
• Experience working in a cGMP/ laboratory / Manufacturing environment required.
• Experience working in a (CMOD)contract manufacturing/development environment preferred.
• Demonstrated proficiency and knowledge of CGMP (FDA and EU), ICH, and other worldwide regulatory requirements
• Direct Quality Control laboratory experience is highly preferred
• Ability to work independently and in compliance with cGMPs

EDUCATION:

• Bachelor's degree in a scientific field with 10 years' experience in a CGMP environment

QUALITIES:

• Demonstrates excellence with interpersonal behaviors and a positive attitude
• Resilient, can quickly move forward despite challenges
• A drive to achieve results while working with limited supervision
• A strong team player with a desire for collaboration coupled with well-balanced independent thinking
• Honesty, integrity, respect and courtesy with leadership and peers
• Strong commitment to conducting LSNE business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services

PHYSICAL REQUIREMENTS & MENTAL DEMANDS:

• Capacity to work on several tasks simultaneously.
• Able to organize and prioritize work activities.
• Must be able to walk and drive between locations
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves

COMMUNICATIONS & CONTACTS:

• Works closely with the Quality Control organization in performing varied activities.
• Interacts with all departmental staff to coordinate activities.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES:

• This is an individual contributor role leading and driving Quality Control compliance through influence and expertise, and a high level of collaboration.

TRAVEL: <10%

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.