Job details
Job type full-time
Full job description
When you’re part of the team at thermo fisher scientific, you’ll do important work, and you’ll be valued and recognized for your performanceWith talented managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world.
The drug product division - north america (dpd-na) is one of the five divisions that make up the pharma services groupWe specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
How will you make an impact?
You’ll be responsible for developing, leading and implementing a multiyear, transformational operational plan to advance compliance, drive continuous improvement, and exploit the collective expertise of the qc laboratories and overall quality system within the drug product division (dpd), north american (na) regionThe role serves as the strategic driver of quality compliance excellence for the dpd na region.
What will you do?
Evaluate the functional strengths and developmental areas in the dpd na qc lab and overall quality organization while relentlessly driving continuous improvement
Actively participates as a member of the dpd eu & na quality leadership team and partners with operations management and the dpd eu region to achieve annual goals
Build and/or assist with the creation of site specific roadmaps for reaching full qc laboratory automation in alignment with strategic plans (e.g., quality strap)
Drive quality across the north american region that embodies our 4i values of integrity, intensity, innovation, and involvement, and embraces our core competencies of putting the customer first, owning your results, and finding a better way every day
Establish a system to measure and report monthly and quarterly program progress (e.g., metrics, trending reports, etc.) and reports program benefits (e.g., cost savings, efficiency improvements, etc.)Analysis of the program`s results will generate a set of recommendations and revisions to the go forward annual plan.
Actively leads adherence to agreed to qc lab compliance-related and/or practical process improvements (ppi)-related improvement plans within the dpd na region.
Provide regional expertise and support in the development, implementation, and management of cgmp compliant quality systems, such as investigations, deviations, capa, and product/customer complaints for fulfillment of qc testing
Support establishment and/or enhancement of quality control metrics (in agreement with na/eu region and with qlt endorsement)
Optimize compliant qc laboratory practices, systems, programs, etcThrough identification and sharing of best practice (to include ensuring data integrity compliance)
Lend analytical and/or technical support to sites (through direct support, facilitation of regional/division assistance, or identification of outside smes) as needed to assist with the resolution of laboratory investigations, analytical method transfers, etc.
Assist with planning and implementation of automation projects as needed (this includes participating in projects such as continuous manufacturing processing, pat applications to create online testing opportunities, etc.)
Participate in external engagement with relevant industry groups and forums in order to maintain knowledge and awareness of latest technological innovation, current thinking of global regulatory authorities, and/or industry advancements
How will you get here?
Education
Bachelors degree in a scientific/technical subject area or related fieldAdvanced degree preferred.
Experience
Experience in a gmp environment (qa, qc, manufacturing) within the pharmaceutical industryQc and/or microbiology laboratory experience highly preferred.
Experience with toyota production system or danaher business system is preferred
Knowledge, skills and abilities
Proven efficiency working and leading in a matrix environment
Excellent influencing and communication skills both oral and written
Solid understanding of fda regulatory requirements applicable to pharmaceuticals, ema knowledge preferred
Ability to apply gmp regulations and international guidelines to all aspects of the position
Advanced knowledge of laboratory quality systems
Solid understanding of pharmaceutical manufacturing and/or outsourcing
Demonstrated track record of leading and/or achieving operational transformation and process improvement
Ability to travel up to 80% on an annual basis
At thermo fisher scientific, each one of our 80,000 extraordinary minds has a unique story to tellJoin us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
