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Director of Quality Assurance

2 months ago

Middleton, United States LGC Biosearch Technologies Full time
Job DescriptionJob DescriptionCompany Description

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Our high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range.

Our tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimize food production; and continuously monitor and enhance the quality of food, the environment and consumer products.

LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community.  Join us and help us achieve our mission of Science for a Safer World 

Our kit and component manufacturing sites are situated across the US (Middleton, Petaluma, and  Novato) and Europe (Berlin and Lystrup) and are underpinned by either ISO 13485 or ISO 9001 compliance. These capabilities support a wide portfolio of off-the-shelf components and kits critical to NGS workflows including magnetic beads, oligos, enzymes, and library prep kits. Additionally, our primary manufacturing capabilities enable customization and bulk (OEM) manufacture of reagents such as key NGS enzymes for high volume applications.

Job Description

Based out of the company’s operational site in Middleton, WI, the Director of Quality Assurance, Reagents & Instrumentation will lead a team of Quality Assurance (QA) professionals across a cluster of operational sites dedicated to product manufacture and delivery in the following product portfolios or technologies: Instrumentation, Workflows, and Reagents. This individual serves as the principal QA business partner of this product portfolio, leading a team spanning multiple sites and/or countries, to ensure effective people management, alignment of QA priorities, and achievement of functional goals in support of the broader business operations and customers.

Travel & Time Expectations: Travel, away from local operational site, up to 30% of working time is expected. International Travel is required.  Overseeing the following sites, Alexandria, Middleton, Hoddesdon, and Berlin.   This position may be required to work evening and/or weekend hours beyond standard hours of operation in support of business and customer needs.

  • Lead relevant QA team across a cluster of operational sites to deliver on QA operational activities, while also ensuring compliance with applicable quality, safety, and regulatory standards
  • Responsible for personnel activities of direct reports and broader team, including budgeting, staffing, training, performance evaluations, mentoring and coaching, and goal setting including setting employee objectives linked to business initiatives and other key performance indicators
  • Serve as the principal QA business partner to business and senior management within product portfolio, providing guidance in the areas of operational quality assurance, compliance, and risk management
  • Partner effectively with functional stakeholders across the company to lead and implement transformational efforts for improving product quality and driving a culture that values and promotes compliance, customer satisfaction, safety, quality, teamwork and goal achievement
  • Oversee the performance of internal and external audits at operational sites under direct remit
  • Ensure the effective creation, review, and maintenance of all respective QA policies, procedures, and processes focused on product design verification, validation, and transfer; documentation control for release of commercialized product/services; change and risk management; corrective and preventive actions; complaint resolution and root cause investigation
  • Oversee the engagement and development of employees and talent necessary to reach annual and long-term objectives as organizational leader for the QA function within respective product portfolio
  • Lead local and global projects outside of direct daily operational remit
  • Develop and maintain mutually beneficial partnerships with other functional leaders, including but not limited to: Manufacturing Operations, Regulatory Affairs, Commercial, Marketing, R&D, HR, Finance
  • Conscientiously learn and diligently follow the requirements of the site’s quality management system
  • Perform other duties as required, or assigned by management, to meet business needs
Qualifications

Qualifications:

  • Bachelor's degree is required, Graduate Degree preferred.  
  • Prior working experience in an in vitro diagnostics, biotechnology, or biopharma organization is strongly preferred. 
  • Prior working experience in a GMP-certified manufacturing environment is preferred. 
  • Proven expertise with a cloud-based quality management system, ideally ETQ Reliance is preferred.
  • Experience managing the QA function and delivery of associated operational processes at an operational site, or multiple sites, with revenues of $50 million or more within an ISO-certified manufacturing environment.
  • Experience managing and developing business staff, with the demonstrated ability to effectively lead and manage a team in a dynamic working environment
  • Experience directing and chairing large-group engagements, such as customer or supplier audits, ISO (re)certifications, and company management reviews
  • Demonstrated experience leading cross-functional risk analyses (e.g. FMEA, FTA, Risk Ranking/Filtering) and root cause investigations throughout the product manufacturing lifecycle.


Additional Information

What we offer (US based-employees):

  • Competitive compensation with strong bonus program
  • Comprehensive medical, dental, and vision benefits for employees and dependents
  • FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
  • Deductible Buffer Insurance and Critical Illness Insurance
  • 401(k) retirement plan with matching employer contribution
  • Company-paid short- and long- term disability, life insurance, and employee assistance program
  • Flexible work options
  • Pet Insurance for our furry friends
  • Enhanced Parental leave of 8 additional weeks
  • PTO that begins immediately
  • Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

All your information will be kept confidential according to EEO guidelines.