Validation Manager (ADX-127-20)

| Greater Boulder Area
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Validation Manager (ADX-127-20)
 

THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

 
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
WORK ENVIRONMENT:
  • This position operates in a professional office and in a cGMP Manufacturing environment
  • The job requires an individual to routinely use standard office equipment such as computers, phones and photocopiers
  • The job requires an individual to occasionally use test equipment in an IVD manufacturing environment (including but not limited to biosafety flow hoods, spectrophotometers, balances, mixers, etc.)
 
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Technology we use

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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