Associate Director / Device Lead
GSK
4 months ago
Remote friendly (Collegeville, PA)
United States
Operations
Responsibilities:
- Serve as SPOC technical SME interface between Device/Component suppliers and GSK MSAT site teams; provide device-related technical management for business improvement and risk management projects; represent MSAT at supplier technical and project meetings.
- Collaborate with Strategy, Procurement, Quality, Logistics, etc. to deliver a robust Device platform supply strategy, including mould tool & assembly asset validation programmers.
- Lifecycle manage the Device Platform, driving technology transfer from R&D and maintaining throughout the platform life (post-approval regulatory change management, continued process verification), improving manufacturing efficiencies and reducing COGs.
- Ensure global device/component manufacturing processes are capable, efficient, and meet specifications.
- Own and maintain Device design and regulatory DHF/technical file requirements; standardize global Device supply; maintain compliance with internal procedures and relevant external standards (e.g., FDA 21 CFR 820, (EU) 2017/745, MDR, ISO 13485, ISO 14971, ISO 10993).
- Support Device Director/Device Strategy/Device Procurement on Continuous Improvement and business projects within Global Supply Chain to deliver MSAT objectives.
- Cross-functionally communicate global device challenges/successes to ensure technical and commercial success of drug delivery devices and integral combination products.
- Drive innovation with new device technologies/ways of working; champion business cases for sustainable manufacturing technology implementation and strategic projects (quality by design, design for manufacturing, design control, digital data management, analytical competency).
- Perform risk management activities (e.g., risk file review/approval); lead risk management as “risk owner” when required.
Basic qualifications:
- Bachelor’s in engineering or science (e.g., Process/Mechanical Engineering, Materials Science, Biomedical Engineering/Chemistry).
- 10+ years’ experience in Medical Device/pharmaceutical manufacturing environment.
- OR Masters degree with 5+ years’ experience.
- Experience in pharmaceutical and/or medical device GMP/regulatory environment; relevant ISO standards; medical device legislation needs (e.g., DHF, MDR, FDA Medical Device guidance).
Preferred qualifications/skills:
- Knowledge of pharmaceutical development, product development, NPS, and technology transfer.
- Experience managing device assembly, metrology & plastics testing; GSK specification/drawing systems.
- Experience leading device groups in a global matrix environment; successful global asset lifecycle management.
- Independent operation and ability to manage multiple global internal/external stakeholders.
- Strong interpersonal/leadership and communication skills; excellent judgment and decision implementation.
- Working understanding of data science (digital data infrastructure, visualization, statistical analysis).
- Knowledge of GMP, ICH Guidelines, FDA QSR, EU MDR; regulatory registration processes (FDA, EMA, MHRA).
- Specialization in regulations and ISO standards; device and combination product regulations (21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971).
- Knowledge of injection mould tooling design/processing, device polymers/materials, springs/wire forming, device testing & lab management, mathematical modelling, automated device assembly techniques.
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary range $142,725–$237,875.
Benefits (as stated):
- Annual bonus; share-based long-term incentive eligibility.
- Health care/insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.
Application instructions:
- Not provided in the job description text provided.
- Serve as SPOC technical SME interface between Device/Component suppliers and GSK MSAT site teams; provide device-related technical management for business improvement and risk management projects; represent MSAT at supplier technical and project meetings.
- Collaborate with Strategy, Procurement, Quality, Logistics, etc. to deliver a robust Device platform supply strategy, including mould tool & assembly asset validation programmers.
- Lifecycle manage the Device Platform, driving technology transfer from R&D and maintaining throughout the platform life (post-approval regulatory change management, continued process verification), improving manufacturing efficiencies and reducing COGs.
- Ensure global device/component manufacturing processes are capable, efficient, and meet specifications.
- Own and maintain Device design and regulatory DHF/technical file requirements; standardize global Device supply; maintain compliance with internal procedures and relevant external standards (e.g., FDA 21 CFR 820, (EU) 2017/745, MDR, ISO 13485, ISO 14971, ISO 10993).
- Support Device Director/Device Strategy/Device Procurement on Continuous Improvement and business projects within Global Supply Chain to deliver MSAT objectives.
- Cross-functionally communicate global device challenges/successes to ensure technical and commercial success of drug delivery devices and integral combination products.
- Drive innovation with new device technologies/ways of working; champion business cases for sustainable manufacturing technology implementation and strategic projects (quality by design, design for manufacturing, design control, digital data management, analytical competency).
- Perform risk management activities (e.g., risk file review/approval); lead risk management as “risk owner” when required.
Basic qualifications:
- Bachelor’s in engineering or science (e.g., Process/Mechanical Engineering, Materials Science, Biomedical Engineering/Chemistry).
- 10+ years’ experience in Medical Device/pharmaceutical manufacturing environment.
- OR Masters degree with 5+ years’ experience.
- Experience in pharmaceutical and/or medical device GMP/regulatory environment; relevant ISO standards; medical device legislation needs (e.g., DHF, MDR, FDA Medical Device guidance).
Preferred qualifications/skills:
- Knowledge of pharmaceutical development, product development, NPS, and technology transfer.
- Experience managing device assembly, metrology & plastics testing; GSK specification/drawing systems.
- Experience leading device groups in a global matrix environment; successful global asset lifecycle management.
- Independent operation and ability to manage multiple global internal/external stakeholders.
- Strong interpersonal/leadership and communication skills; excellent judgment and decision implementation.
- Working understanding of data science (digital data infrastructure, visualization, statistical analysis).
- Knowledge of GMP, ICH Guidelines, FDA QSR, EU MDR; regulatory registration processes (FDA, EMA, MHRA).
- Specialization in regulations and ISO standards; device and combination product regulations (21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971).
- Knowledge of injection mould tooling design/processing, device polymers/materials, springs/wire forming, device testing & lab management, mathematical modelling, automated device assembly techniques.
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary range $142,725–$237,875.
Benefits (as stated):
- Annual bonus; share-based long-term incentive eligibility.
- Health care/insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.
Application instructions:
- Not provided in the job description text provided.