POSITION SUMMARY:

This position is responsible for the Management of Validation activities for in-Vitro Diagnostics Manufacturing and related support functions. Maintains and develops a team-oriented Validation workforce. Works with outside entities to complete Validation activities as they relate to ArcherDx, Inc. Cultivates a dedicated team within a fast-paced and growing environment. Builds documentation and process for IVD manufacturing and distribution and maintains/improves systems based on relevant changes in industry.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Develop and maintain the Site Validation Master Plan in support of cGMP requirements and Company Objectives
• Develop and maintain Process Validation Programs and Plans
• Author validation plans, protocols IQ, OQ and PQ, test scripts and reports
• Execute process validation studies and data analysis and compile data and results into summary and final reports
• Work with Validation Team to develop and maintain Validation protocols
• Provide guidance to staff in preparing protocols, executing validation projects, developing approaches and strategies, alignment with internal procedures and industry best practices
• Guide and arrange process validation for new products, technical transfers, sustainability initiatives
• Deliver technical input to strategies and philosophy for process validation activities
• Develop, execute and document risk assessments and evaluations to determine testing strategies and requirements
• Provide technical assessments on change controls, deviations and investigations
• Assess proposed changes to validated processes to identify requirements necessary to maintain validated status
• Participates in audit and inspection preparation and response activities. Supports interactions or interacts with regulatory agencies
• Participates in client audits and regulatory inspections and audits as needed
• Presents and/or defends cGMP documentation associated with quality validation practices
• Establishes validation best practices, process validation strategy and maintenance and management of validation processes to be used as a guide for future projects and products at ArcherDX
• Subject matter expert for process validation topics
• Supports change controls, deviations and CAPAs relevant to process validation topics
• Conducts validation workshops and provides site wide validation training as necessary
• Motivates, retains and develops key employees. Develops employees and ensures adequate skill sets in accordance with Talent Management based on performance dialogue, performance evaluation and individual career development plans, including training plans
• Ensures that the right skills and capabilities of people in the Validation function are developed to enable the organization to be flexible/adapt to dynamic business conditions
• Maintain safe and healthy work environment by establishing, following and enforcing standards and procedures, and complying with regulations (e.g., 21 CFR 820, ISO 13485, FDA Guidances)
• Support employee communication with senior management
• Communicate policies and information to department from senior management
• Develop and maintain a thorough understanding of ArcherDX clients and the IVD assay market
• Help promote a company culture that encourages top performance and high morale
• Maintain ArcherDX values and mission within department and cross functionally, and plan for short and long-term goals and objectives within the department and company
• Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures
• Safeguarding the privacy and security of protected health information and European Union personal data
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology

EDUATION:

• Bachelor’s degree in Scientific or Engineering field from an accredited institution. Advanced degree a plus.

EXPERIENCE:

• Minimum of seven years in a regulated healthcare industry (IVD, Pharma, Medical Device) with direct experience in a cGMP environment
• Minimum of Four (4) years of experience managing/directing people and projects
• Advanced knowledge of relevant regulations and guidance required in order to act as a resource for colleagues
• Previous experience with manufacturing of class 2 and preferably class 3 Medical Device
• Knowledge of Validation Lifecycle Approach
• History of successful performance in a fast-paced environment with a proven ability to make important decisions, often under pressure and tight deadlines
• Experience managing complex cross-function projects/programs

KEY ATTRIBUTES:

• Functional knowledge of key business processes in a medical device manufacturing environment.
• Expert proficiency at managing day-to-day aspects of a project and scope
• Demonstrate the ability to manage projects and teams, multi-task and achieved desired results, especially under pressure
• Demonstrate initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision
• Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making
• Independent decision-making capability and ability to think conceptually and understand impact of decisions critical to product quality
• Demonstrate strong verbal, listening and written communication skills, organizational and time management skills, presentation skills and attention to detail
• Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company
• Ability to translate broad strategies into specific objectives and action plans
• Ability to foster and maintain relationships with individuals representing a wide diversity of disciplines and levels of sophistication in a collaborative environment
• Ability to influence, develop, motivate and empower employees to achieve objectives with a team approach
• Ability to build consensus and relationships among managers, partners, and employees
• Deadline and deliverable driven individual with an ability to adapt to/in unexpected or abnormal results or situations
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company
• Self-starter driven to perform with the ability to organize, prioritize, and delegate tasks to efficiently move projects forward

SUPERVISORY RESPONSIBILITY:

• This position supervises a team of 5-10 Validation Engineers and Technicians