Senior Manager, Post Market Compliance

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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.

This position is responsible for managing the operations of the Post Market Compliance functions, such as Field Actions, Stability Testing, Adverse Event Reporting, Post-Market Surveillance, and Product Complaints.

The role maintains collaborative relationships with the other functional areas and is responsible for overseeing the activities of their assigned teams to ensure the effectiveness of the Quality System.

This position develops plans to manage work assignments and processes to meet productivity standards, quality goals and department objectives.

Responsible for providing support to staff, resolving operational and performance issues, and implementing improvements to operations, processes, and the work environment.

Trains and onboards new staff, assesses performance of direct and indirect reports and provides development opportunities.

Ensures business goals, deadlines and performance standards are met. Communicates and collaborates with lower-level management, staff, department Senior Leadership, and other Autoimmunity functions to meet goals and produce the highest quality products and services.

Ensures staff comply with company policies and expectations. All activities are performed in accordance with standard operating procedures, Quality System, safety, and administrative regulations.

Key Accountabilities

• Department Management
• Implements strategies to achieve company objectives. Ensure staff understand objectives and expectations related to them.
• Manages 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.
• Ensures 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.
• Educates and broadens the Quality, Compliance, and technical knowledge within the teams; develop and deploy personnel skill assessment and training plans.
• Ensures 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.
• Manages and leads 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 assurance 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
• Reviews trends, analyzes and identifies continuous improvement opportunities and coordinates / performs actions to improve processes and metrics;

proactively manages critical quality issues.

• Contributes, manages, and executes proactive quality strategies and plans.
• Creates and maintains productive relationships with other departments and promotes collaboration within Autoimmunity and other Werfen manufacturers and Affiliates.
• Ensures risks to Quality Systems are identified and mitigated through effective controls.
• Influences and drives cross-functional projects for quality improvement.
• Recommends Quality objectives and ensure they are monitored and achieved.
• Ensures Quality System effectiveness through audits, data analysis, and projects to achieve company and department objectives.
• Complaints
• Provides technical and administrative guidance to product complaint personnel on complaint investigation strategies and resolution.

Ensure escalation of product issues, timely and appropriate customer communications, and accurate investigation and corrective action documentation.

• Reviews completed complaint investigations for thoroughness, completeness and accuracy. Ensure alignment between level of investigation and risk of the potential deficiency.
• Provides advance troubleshooting guidance to Affiliates and customers in collaboration with internal departments.
• Ensures trending product issues are presented to the Quality Review Board and non-quality issues are presented in On-Market meetings.
• Administrates status of complaints to ensure timely closure and KPIs are maintained.
• Post Market Surveillance (PMS)
• Provides oversight of adherence to PMS report and reporting schedules.
• Reviews PMS documentation for completeness, accuracy, and adherence to geographic regulations.
• Provides regulatory and timely communication of PMS data and / or trend analysis throughout the organization to identify improvement opportunities.

Ensure transfer of action items into CAPA and Design Control systems.

• Manages correspondence with regulatory agencies related to post market surveillance, field actions, and reportable events.
• Confirms the maintenance of PMS reports and supporting documentation records.
• Ensures the assessment of potentially reportable incidents, adverse events, and device malfunctions; the documentation of the investigation and reporting decision;

the submission of any necessary reports to global regulatory agencies to ensure compliance with regulatory requirements for medical device safety reporting.

• Manages the coordination of subject matter experts and clinicians in performing Health Hazard Evaluation. Ensures the assessment, execution, and documentation of Field Actions per global regulatory requirements.
• Post Market Product Monitoring
• Oversees the design, protocol development, sample management, protocol execution, data analysis, and documentation of stability studies according to regulatory guidelines and company protocols to ensure scientific and technical compliance.
• Ensures creation, implementation, management of product data databases used to perform trending, statistical analysis, product performance forecasting, and reporting of metrics.

Technically reviews data interpretation to confirm accuracy. Manages escalations, notifications and responses, to data results.

• Ensures the preparation of comprehensive stability reports and summaries for regulatory submissions and internal reviews.
• 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
• Quality, Product Support and Regulatory teams
• R&D teams including Manufacturing Technical Support
• Contract Manufacturers
• Customers
• Senior Management
• Affiliates and Distributors
• Other Werfen departments and staff

Minimum Knowledge & Experience required for the position :

Education :

Masters’s degree in molecular biology, immunology, microbiology, biochemistry, or related life science, bioengineering, or equivalent required. Advanced degree preferred.

Experience :

• A minimum of 10 years of progressive experience in in-vitro diagnostics manufacturing industry in research, complaints, technical support, post-market surveillance and / or product testing.
• At least 8 years of experience managing or leading junior level management and teams required, preferably in an FDA regulated manufacturing environment.
• Five years or greater of medical laboratory experience, preferred.
• Experience in interacting and communicating with end-customers, preferred.

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 knowledge of current compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, or other regulations and standards).
• Advanced knowledge of quality principles including risk management industry practices, and standards with demonstrated application.
• Advanced knowledge and ability to apply Lean Principles in the organization to re-engineering and maintain scalable processes.
• Advanced ability to interpret and apply compliance and Quality Systems requirements.
• Proven track record of building and managing successful business operations and high performing teams required.
• Advanced operational understanding of employment laws and experience monitoring for compliance and prevention of employee relations issues.
• Understanding of standard finance and budgeting processes, including profit and loss, balance sheet and budget management.
• Working interpersonal and emotional intelligence skills to develop and lead a high performing team.
• Advanced ability to lead, collaborate and influence cross-functional teams to achieve common goal, with or without direct authority.
• Advanced ability to effectively manage multiple concurrent assignments and proactively independently identify, assess risk for, and develop proactive and creative approaches to barriers to success.
• Advanced ability to constructively prevent and resolve conflicts.
• Critical thinking capability and decision making.
• Advanced ability to function effectively with ambiguity in a rapidly changing environment.
• Advanced ability in influencing and negotiation while building collaborative relationships and maintaining strong, positive working relationships.
• Advanced ability to independently identify, assess risk for, and mitigate.
• Advanced ability to be self-motivated, proactive, accountable hands-on, and flexible.
• Advanced ability to apply sound, systematic problem-solving methodologies and root cause investigation to identify, prioritize, communicate, and resolve quality issues.
• Advanced ability delivering effective presentations and training material.
• Advanced skills in verbal and written communication including presentations.
• Advanced skills in Microsoft Office Suite : Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.
• Working data-driven, analytical skills.

Travel Requirements :

No routine travel requirements.

People Manager Core Competencies :

• Building Talent : Planning and supporting the development of individuals’ knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively.
• Customer Focus : Ensuring that the internal or external customer’s perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities;

crafting and implementing service practices that meet customers’ and own organization’s needs; promoting and operationalizing customer service as a value.

• Decision Making : Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information;
• choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions;

taking action that is consistent with available facts and constraints and optimizes probable consequences.

Driving for Results : Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals;

tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.

Driving Innovation : Creating an environment (culture) that inspires people to generate novel solutions with measurable value for existing and potential customers (internal or external);

encouraging experimentation with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions.

Emotional Intelligence Essentials : Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others’ emotions and behavior;

leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results.

People Manager Accountabilities : Effectively carries out the expectations of Werfen People Managers as defined in Werfen’s Role of the Manager program.

Among others this includes maintaining regular, at minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets.

Managing performance issues and conflict proactively; uses judgement in consulting with department leadership and Human Resources.

Responsibility for the team s compliance in terms of training, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team.

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.

This position is very active and requires varying levels of mobility.

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