Sr. Manager, Quality System IVD Medical Device

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.

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 companys 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 Werfens 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.

Networking/Key relationships

• Manufacturing teams
• Regulatory teams
• R&D teams including Manufacturing Technical Suppor
• Contract manufacturers
• Quality Control
• Product Complaint Group
• Suppliers
• Senior and Executive Management
• Affiliates
• Other Werfen Affiliate and Manufacturers functions

Minimum Knowledge & Experience required for the position:

Education:

• Bachelors degree in biology biochemistry life science engineering or equivalent required. Advanced degree preferred.
• Certified Medical Device Auditor (preferred).

Experience:

• 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.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• 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.

Travel requirements:
No routine travel requirements.

Location / Office

• Must reside in the San Diego area
• Must be present in the office Mon Friday

Supervisory Experience

• Prior experience managing direct reports is required

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job the employee is regularly required to communicate. Must be able to detect identify and inspect scientific data. 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. The noise level in the work environment will vary but is usually moderate.

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities duties and skills required of this position.Note this job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice.This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The annual base salary range for this role is currently $135000 range to $195000 range. Individual employee compensation will ultimately depend on factors including education relevant experience skillset knowledge and particular business needs.

This role is eligible for medical dental and vision insurance 401k plan retirement benefits with an employer match as well as paid vacation and sick sales roles are eligible for participation in a commission plan and our managementand select professional rolesare eligible for a performance-based bonus.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals race color religion gender sexual orientation gender identity/expression national origin/ancestry age mental/physical disability medical condition marital status veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.