POSITION SUMMARY:

The Senior Manager of Quality Control will be primarily responsible for the Quality Control laboratories. This position will be responsible for hiring and developing the personnel, leading the laboratory and process improvements to ensure that the Archer provides its internal and external customers with industry leading and innovative products and services. This role shall lead the QC lab to establish and maintain quality levels that consistently deliver best-in-class products that comply with US FDA Regulations and ISO 13485:2016. Function includes direct, solid-line management and oversight for Quality Control teams.

RESPONSIBILITIES:

• Promote quality culture throughout Archer, ensuring compliance to policies, procedures, and regulations sustained through reinforcement of quality at all levels.
• Oversee the quality control program including development of staff and process improvements for test method validation, material release, and stability.
• Lead by example to create an inclusive culture that values high engagement.
• Work with internal and external resources to maintain QC laboratory infrastructure including equipment, reagents, etc.
• Establish department goals and accomplish results within budget and on schedule.
• Build and maintain positive and collaborative relationships cross-functionally to develop and improve the method transfer and phase appropriate qualification/validation of methods.
• Monitor and trend data including routine record review of test data.
• Gather data for continuous process improvement.
• Develop, revise and review SOPs, qualification/validation protocols and reports

KEY ATTRIBUTES:

• Passion for enhancing healthcare outcomes with novel technology
• Problem solver comfortable operating in the grey-space and driving forward with risk balanced decision making
• Must exemplify Archer’s values: Accountability, Care, Trust, Grit & Urgency
• History of thriving in a fast-paced, dynamic environment
• Inspirational people leader with a history of managing teams to deliver their best work
• Able to organize, prioritize, and delegate tasks to efficiently
• Excellent oral and written communication skills.

EXPERIENCE:

• Associate Director: Minimum of 10 years experience in Quality roles with a minimum of 8 years in a laboratory setting and 5 years in a leadership position
• Senior Manager: Minimum of 7 years experience in Quality roles with a minimum of 5 years in a laboratory setting and 3 years in a leadership position
• Working knowledge of regulatory requirements ISO13485:2016, ISO 14971:2012, CFR 21 820. CAP CLIA and laboratory standards preferred.

EDUCATION:

• Bachelor's degree required; Master’s Degree preferred

SUPERVISORY RESPONSIBILITY:

• This position has direct supervisory responsibilities