Integrated DNA Job - 43277034 | CareerArc
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Company: Integrated DNA
Location: Coralville, IA
Career Level: Director
Industries: Healthcare, Pharmaceutical, Biotech

Description

IDT is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Job Title: Director of Quality Assurance

Location:  Coralville, IA ​*Mobile/Remote (On-Site/Work from Home Hybrid)*

-Mobile associates must live in an area that does not exceed a 100-mile (150 km) radius of an IDT location. *May require on-site occasional presence for team meetings, etc.

Purpose Statement:

The Director of Quality Assurance provides management of the Quality function related to IDT Therapeutics and API manufacturing, including all major quality system functions and requirements for IDT's regulated products related to next-generation sequencing, CRISPR, and API manufacturing. 

This role is accountable to ensure compliance with Q7 API manufacturing requirements, GMP requirements, and internal processes and procedures.   Responsibilities include: design quality for new product introduction, production and process controls, product compliance, ISO/MDSAP certifications and third-party audits. This role will also support all GMP manufacturing, represent QA on project core teams, and drive continuous improvement activities across the entire function. 

                                                                                                                              

Job Specific Duties/Essential Functions:

  • Primarily manages QA activities, such as those listed in the purpose statement for therapeutic and API materials

  • Represent QA on applicable strategic initiatives and policy deployment

  • Provides direct support for QMS by processing of quality events, creation of necessary SOPs, developing and auditing of processes and providing QA expectations for manufacturing of therapeutic and API materials

  • Strong, and active, partner with product development and operations

  • Develop, review, continuously improve, and accountable for reporting on daily management activities for QA and QMS processes at the API site

  • Develop, review, continuously improve and accountable for KPIs, including ownership and management of KPI meetings related to API materials

  • Provide information to support product quality reviews as required by Q7

  • Plan, prepare, execute, and close-out audits (internal / external) from customer, BSI, Danaher Corporate and other regulatory agencies.  Serve as QA subject matter expert on all QMS related therapeutic and API processes.

  • Maintains an up-to-date knowledge of and provides expertise in the areas of QA compliance to Q7 and API manufacturing requirements.  

  • Interacts professionally and efficiently with global QMS staff and provides recommendations for collaboration on improvement efforts.

  • Develop and refine programs to maintain compliance with IDT QA policy, ISO13485, Q7 and 21CFR Part 820 FDA Quality System expectations.

  • Prepares reports of quality system performance for internal departmental use as well as management review meetings.

  • Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.

  • Performs other duties as assigned.

Education, Licensure, Certification, Registration:

  • Bachelor's degree in engineering or science related field required (or equivalent experience), preferred.

Professional Experience:

  • 8+ years' experience and familiarity with Quality System requirements to meet compliance FDA Q7 requirements and FDA QSR/cGMP standards, required.

  • Experience with execution of customer audits, notified body and regulatory based audits, required.

  • Experience with creation and implementation of QMS standard work, required. 

Other Knowledge, Skills, and Abilities:

  • Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.

  • Comfortable with learning advanced calculations and reporting with Microsoft Office applications (emphasis in Excel, Word, PowerPoint).

  • Comfortable in a role of authority and guidance on QMS requirements. 

  • Ability to drive initiatives to a successful conclusion.

What We Offer:

  • Generous Paid Time Off Accruals

  • 16 Hours PAID Volunteer Time Off

  • 10 Paid Holidays

  • Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates

  • 401(k) with Company Match

  • Medical, Dental, and Vision Insurance Options

Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.

When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.  Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.



Responsibilities

May require on-site occasional presence for team meetings, etc. The Director of Quality Assurance provides management of the Quality function related to IDT Therapeutics and API manufacturing, including all major quality system functions and requirements for IDT's regulated products related to next-generation sequencing, CRISPR, and API manufacturing. This role is accountable to ensure compliance with Q7 API manufacturing requirements, GMP requirements, and internal processes and procedures. Responsibilities include: design quality for new product introduction, production and process controls, product compliance, ISO/MDSAP certifications and third-party audits. This role will also support all GMP manufacturing, represent QA on project core teams, and drive continuous improvement activities across the entire function. Primarily manages QA activities, such as those listed in the purpose statement for therapeutic and API materials. Represent QA on applicable strategic initiatives and policy deployment. Provides direct support for QMS by processing of quality events, creation of necessary SOPs, developing and auditing of processes and providing QA expectations for manufacturing of therapeutic and API materials. Strong, and active, partner with product development and operations. Develop, review, continuously improve, and accountable for reporting on daily management activities for QA and QMS processes at the API site. Develop, review, continuously improve and accountable for KPIs, including ownership and management of KPI meetings related to API materials. Provide information to support product quality reviews as required by Q7. Plan, prepare, execute, and close-out audits (internal / external) from customer, BSI, Danaher Corporate and other regulatory agencies. Serve as QA subject matter expert on all QMS related therapeutic and API processes. Maintains an up-to-date knowledge of and provides expertise in the areas of QA compliance to Q7 and API manufacturing requirements. Interacts professionally and efficiently with global QMS staff and provides recommendations for collaboration on improvement efforts. Develop and refine programs to maintain compliance with IDT QA policy, ISO13485, Q7 and 21CFR Part 820 FDA Quality System expectations. Prepares reports of quality system performance for internal departmental use as well as management review meetings. Demonstrates behavior consistent with the Integrated DNA Technologies Core Values. Performs other duties as assigned.


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