Sr. Manager, Quality System/ IVD Medical Device

Werfen•San Diego, CA

3d•Onsite

About The Position

Overview Job Summary Autoimmunity Sr. Managers are responsible for managing the overall operations, business results and performance for their assigned department(s). Responsible for department functional plans, determining current and future position profiles and staffing needs, proposing and managing department budgets, performance metrics and reporting, analyzing operations to identify gaps, ensure compliance, safety, and ongoing process improvements, as well as leading and developing lower-level management staff and high performing teams. The Sr. Manager, Quality System leads by setting a clear vision, fostering collaboration across teams, and driving continuous improvement in quality management. This role empowers staff through coaching and feedback, ensures accountability for results, and models company values and compliance. The Sr. Manager proactively maintains collaborative relationships across the organization to meet goals and produce complaint products and services. The position oversees organizational activities to ensure the effectiveness of the Quality Management System. All activities are performed in accordance with standard operating procedures, Quality Management System, safety, and administrative regulations. Responsibilities Key Accountabilities Department Management Implement strategies to achieve company objectives. Ensure staff understand objectives and expectations related to them. Manage department headcount budget to ensure effective resource planning, including recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management. Ensure effective use of company’s performance management program, including setting expectations, providing timely and meaningful feedback, ensuring understanding, holding staff accountable, while supporting employees’ development goals. Educate and broaden the Quality knowledge within the teams; develop and deploy personnel skill assessment and training plans. Ensure regular and meaningful communication throughout team, and with department management, through effective use of one-on-one meetings, team meetings and other forms of formal and informal communication. Manage and lead lower-level management staff to ensure high performing teams and department operations. Includes accountability to Werfen’s People Manager Competencies and Expectations. Monitors department personnel and operations to pre-empt employee issues. Proactively manages employee relations issues; uses judgement in consulting with department senior leadership and Human Resources. Assesses the need for new or improved operations. Delegates responsibility or may directly author, implement, and ensure maintenance of departmental procedures, work instructions, and templates associated with the quality System activities. Develops metrics and data collection methodologies, interprets data to make recommendations to Department Senior Leadership and prepare reports on the performance of the quality system, including management-requested reports and management review meetings minutes. Proposes department budget and monitors department expenditures. Continuous Improvement Work closely with management by contributing to and proactively driving strategies and plans to achieve Quality Objectives. Ensure Quality Management System effectiveness by driving continuous improvement, implementing controls and mitigating risks using audits and data analysis; coordinating actions to improve processes and metrics; and proactively managing critical quality issues. Foster productive relationships and collaboration within Autoimmunity, Werfen manufacturers, and Affiliates. Lead and manage department and cross-function projects as well as operational tasks Quality System Activities Ensure Quality Management System efficiency using data-driven tools across corrective and preventive actions, internal & external audits management, document & records management, compliance administration, stop shipment management, change management, quality system training, management review, supplier management, quality improvements, quality monitoring and reporting, and nonconformance/deviations management. Facilitate a quality culture and promote collaboration, quality requirements understanding and continuous improvement by actively engaging with other organizational functions. Acquire and maintain current knowledge of regulatory compliance and industry practices through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches. Document Control Develop and maintain document control policies and procedures tailored to IVD regulatory requirements. Manage the creation, review, approval, revision control, change traceability, distribution, and archival, and retrieval of controlled documents and quality records. Administer and optimize Electronic Document Management Systems (EDMS). Educates and supervises staff to ensure compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies. Represents the AID management team and reflects Werfen Values as a role model to employees, suppliers, and customers. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Requirements

Bachelor’s degree in biology, biochemistry, life science, engineering, or equivalent required.
A minimum of 10 years of progressive quality experience in in-vitro diagnostics.
At least 8 years of experience managing or leading junior level management and teams required, preferably in a regulated manufacturing environment.
At least 3 years of successful auditing and inspection experience including managing the preparation for and hosting of Regulatory Inspection including successfully resolving issued nonconformance/violations e.g., 483s.
Advanced expert knowledge of current regulatory Quality Management Systems requirements including US Quality System Regulations (QSMRs), EU in Vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, and other regulations and standards. Apply this knowledge to ensure organizational compliance.
Ability to integrate advanced quality principles, document and record configuration and management, Lean Principles, and risk management into daily operations to optimize scalable processes which will balance compliance with business goals.
Ability to utilize critical thinking and sound systemic decision-making skills to analyze complex situations, evaluate alternatives and implement optimal solutions.
Demonstrates advanced interpersonal and emotional intelligence skills, building trust and report to develop and lead highly functioning teams and collaborate across organizational boundaries.
Ability to function effectively in ambiguous and rapidly changing environment, demonstrating flexibility, adaptability and resilience.
Influences and negotiate with stakeholders to achieve mutually beneficial outcomes, maintain strong, positive working relationships.
Proactively prevent and resolve conflicts, while fostering a constructive and inclusive work environment.
Independently identifies, assesses, and mitigates risks, applying systematic problem-solving methodologies and root cause analysis to prioritize and resolve quality issues.
Demonstrates advanced verbal and written communication skills, including the ability to prepare and deliver effective presentations and training materials, communicating complex concepts clearly to diverse audiences.
Possesses advanced skills in Microsoft Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, Adobe Acrobat), leveraging these tools for data analysis, reporting, and documentation.
Applies data-driven analytical skills to interpret information, support decision-making, and drive continuous improvement initiatives.
Applies a thorough understanding of standard finance and budgeting processes, including profit and loss, balance sheet, and budget management, to support departmental planning and resource allocation.
Knowledge of employment laws and experience in monitoring compliance and addressing employee relations matters.
Must reside in the San Diego area
Must be present in the office Mon – Friday
The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.
Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.
May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.
Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
May occasionally have to lift and/or move up to 25 pounds.

Nice To Haves

Advanced degree preferred.
Certified Medical Device Auditor (preferred).

Responsibilities

Implement strategies to achieve company objectives.
Ensure staff understand objectives and expectations related to them.
Manage department headcount budget to ensure effective resource planning, including recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management.
Ensure effective use of company’s performance management program, including setting expectations, providing timely and meaningful feedback, ensuring understanding, holding staff accountable, while supporting employees’ development goals.
Educate and broaden the Quality knowledge within the teams; develop and deploy personnel skill assessment and training plans.
Ensure regular and meaningful communication throughout team, and with department management, through effective use of one-on-one meetings, team meetings and other forms of formal and informal communication.
Manage and lead lower-level management staff to ensure high performing teams and department operations. Includes accountability to Werfen’s People Manager Competencies and Expectations.
Monitors department personnel and operations to pre-empt employee issues.
Proactively manages employee relations issues; uses judgement in consulting with department senior leadership and Human Resources.
Assesses the need for new or improved operations.
Delegates responsibility or may directly author, implement, and ensure maintenance of departmental procedures, work instructions, and templates associated with the quality System activities.
Develops metrics and data collection methodologies, interprets data to make recommendations to Department Senior Leadership and prepare reports on the performance of the quality system, including management-requested reports and management review meetings minutes.
Proposes department budget and monitors department expenditures.
Work closely with management by contributing to and proactively driving strategies and plans to achieve Quality Objectives.
Ensure Quality Management System effectiveness by driving continuous improvement, implementing controls and mitigating risks using audits and data analysis; coordinating actions to improve processes and metrics; and proactively managing critical quality issues.
Foster productive relationships and collaboration within Autoimmunity, Werfen manufacturers, and Affiliates.
Lead and manage department and cross-function projects as well as operational tasks
Ensure Quality Management System efficiency using data-driven tools across corrective and preventive actions, internal & external audits management, document & records management, compliance administration, stop shipment management, change management, quality system training, management review, supplier management, quality improvements, quality monitoring and reporting, and nonconformance/deviations management.
Facilitate a quality culture and promote collaboration, quality requirements understanding and continuous improvement by actively engaging with other organizational functions.
Acquire and maintain current knowledge of regulatory compliance and industry practices through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches.
Develop and maintain document control policies and procedures tailored to IVD regulatory requirements.
Manage the creation, review, approval, revision control, change traceability, distribution, and archival, and retrieval of controlled documents and quality records.
Administer and optimize Electronic Document Management Systems (EDMS).
Educates and supervises staff to ensure compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies.
Represents the AID management team and reflects Werfen Values as a role model to employees, suppliers, and customers.