Colliers International Property Consultants

Quality Manager, US

Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of experience in operational quality assurance in a regulated environment
  • In-depth knowledge of ISO 13485 and ISO 9001 quality systems
  • Strong leadership abilities with a focus on team engagement
  • Exceptional communication skills across various organizational levels
  • Competent in developing and applying quality standards and practices
  • Experience conducting internal audits and managing CAPA processes

Responsibilities

  • Champion quality management practices for PA in the US and globally
  • Lead and respond to external audits related to QMS and client requirements
  • Maintain QMS, encouraging staff ownership of best practices
  • Deploy eQMS system to enhance compliance and workplace practices
  • Drive organizational change to improve quality performance
  • Develop and implement internal audit plans and manage findings
  • Conduct management reviews and generate strategic reports based on quality performance metrics

Benefits

  • Comprehensive group medical and dental insurance
  • Health Savings Account with company match
  • 401(k) plan with profit sharing contributions
  • Generous paid time off including vacation, holidays, and sick days
  • Gym and health incentive reimbursement programs
  • Financial and legal support benefits
  • Annual performance-based bonus opportunities
Full Job Description
Job Description

We are seeking a US Quality Manager to work in collaboration with our UK Quality Manager to maintain and develop our Quality Management System (QMS), provide leadership for Quality specifically in the US and support globally across the company as a whole. PA's QMS is certified to both ISO9001 and ISO13485, under which we operate a wide range of projects and need to ensure that both our QMS and the development projects comply with best practice, regulations and standards.

Core duties

In collaboration with the UK Quality Manager;
  • Act as the champion for Quality for PA in the US and globally, with a focus on Design, Engineering and Science
  • Front external audits from ISO certification bodies for the QMS and from clients undertaking supplier approval audits for work
  • Be a point of contact to maintain the QMS, provide leadership and engage and help empower staff to take ownership of best practice and codify it in the QMS
  • Support usage and deployment of the eQMS system to drive change in the business that supports staff and improves compliance
  • Drive positive change through the organization to improve working practices, and the QMS itself
  • Develop and deliver the internal audit plan with stakeholders and undertake audits to assess effectiveness of both work and QMS, managing the CAPA process
  • Develop quality metrics and assess performance against and report findings
  • Conduct management review meetings and author the summary reports to assess effectiveness of the business and help develop the strategy and long-term plans
  • Train staff on QMS processes and develop innovative ways to train and engage staff to improve fluency to meet PA's Quality goals and improve the overall culture of Quality
  • Support client projects, specifically in regulated industries, ensuring activities meet relevant Quality standards / design controls for regulated development
  • Serve as a subject matter expert on Quality/design controls on projects
  • Oversee product release and CE marking/UL listing (for self-declaration) where applicable (e.g. for machinery)


Qualifications

The ideal candidate will be enthused by innovation, competent in Quality systems, knowledgeable about regulations and be driven to use their knowledge of product development to ensure that our scientists, engineers, designers and developers deliver a fantastic service that meets the highest standards of Quality. This will involve broad duties to provide leadership in the US for internal QMS activities to ensure that we capture best practice and we remain compliant. We are looking for a natural leader to collaborate with the UK Quality Manager and engage with the management group in PA and with DES staff performing the work. Applicants are not expected to have gained experience across all the industry sectors noted but must have a thorough understanding of ISO 13485 and ISO 9001 quality systems.

About You
  • Competent Quality practitioner
  • Proven experience in operational quality assurance within a regulated environment
  • Strong working understanding of ISO13485, ISO9001 is a plus
  • Strong communication skills
  • Great leadership skills to help inspire staff and coach where needed
  • The ability to develop, learn and apply Quality principles, best practice, and applicable regulations across multiple disciplines and industry sectors

If you are looking for a challenging role in QA covering a wide range of disciplines and diverse projects, where you will have internal and external-facing duties, and the chance to work across industry sectors, then this role might be what you are looking for.

Additional Information

Life At PA encompasses our peoples' experience at PA. It's about how we enrich peoples' working lives by giving them access to unique people and growth opportunities and purpose led meaningful work.

Our purpose guides how we work with our clients and our teams, and support our communities, to deliver insight and impact, solving the world's most complex challenges. We're focused on building a workplace that values human difference and diverse mindsets, and a culture of inclusion and equality that unlocks the potential in our people so everyone can be their best self.

Find out more about Life at PA here.

We are dedicated to supporting the physical, emotional, social and financial well-being of our people. Check out some of our extensive benefits:
  • Group medical insurance
  • Health Savings Account with company match
  • Teladoc and informed nurse line resources
  • Long term care plan
  • Group dental insurance
  • Vision plan
  • 401(k) Savings plan with company profit sharing contribution
  • Commuter and Parking tax-savings benefit
  • 15 days paid vacation with the opportunity to buy five additional days
  • 10 paid holiday days plus 10 paid sick days
  • Company and Voluntary income protection benefits
  • Gym and health incentive reimbursement
  • Pet and legal insurance plans
  • Employee Assistance Plan
  • Annual performance-based bonus


In compliance with Colorado's, New York & Massachusetts's Equal Pay Transparency Act, PA is required to provide a reasonable salary range for this role. This salary range is specific to the State of Massachusetts and is commensurate with experience, market data, applicant skills, internal equity and/or degrees/certifications.

Salary Range:
$ 109,000 - $140,000

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About Colliers International Property Consultants

Colliers International is a leading diversified professional services and investment management company. With operations in 68 countries, our more than 15,000 enterprising professionals work collaboratively to provide expert advice to maximize the value of property for real estate occupiers, owners and investors. For more than 25 years, our experienced leadership team, owning more than 40% of our equity, has delivered industry-leading investment returns for shareholders. In 2019, corporate revenues were more than $3.0 billion ($3.5 billion including affiliates), with $33 billion of assets under management in our investment management segment.
Learn more about Colliers International Property Consultants
Size
16,780 employees
Market Cap
$3.6 billion
Industry
Founded
1976
5 Year Trend
+16.6%
NASDAQ

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