Associate Director / Device Lead
GSK
4 months ago
Remote friendly (Waltham, MA)
United States
Operations
Device Lead of Global MSAT Drug Delivery and Aseptic Technology (Technical owner of the Device platform; globally accountable for Device delivery into GSK Manufacturing sites from the Supply Base). Flexibility required, including international travel where applicable.
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; represent MSAT at supplier technical and project meetings.
- Deliver robust supply strategy for the Device platform by collaborating with Strategy, Procurement, Quality, Logistics, etc., including mould tool & assembly asset validation programs.
- Lifecycle manage the Device Platform; drive Technology Transfer from R&D; manage post-approval regulatory changes, continued process verification, and manufacturing efficiency/COG reduction.
- Ensure global device/component manufacturing processes are capable, efficient, and meet specification.
- Own and maintain Device design including regulatory DHF/Technical file requirements; standardize global device supply; maintain compliance with procedures and external standards (e.g., FDA 21 CFR 820, (EU) 2017/745, MDR, ISO 13485, ISO 14971, ISO 10993).
- Support Device Director, Device Strategy, and Device Procurement on Continuous Improvement and Business projects within Global Supply Chain to deliver MSAT objectives.
- Cross-functionally communicate technical device challenges/successes to ensure technical and commercial success of drug delivery devices and integral combination products.
- Drive innovation via new device technologies/ways of working; champion business cases for sustainable manufacturing technology implementation (quality by design, design for manufacturing, design control, digital data management, analytical competency).
- Perform and lead risk management activities (e.g., risk file review/approval) as required as “risk owner.”
Basic qualifications:
- Bachelor’s in engineering or a Science Degree (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 in Medical Device/pharmaceutical Manufacturing environment.
- 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 activities and R&D processes for product development, NPS, and Technology Transfer.
- Understanding to manage device assembly, metrology & plastics testing techniques/procedures and specification/drawing systems.
- Experience leading device groups in a global matrix with successful global asset lifecycle management.
- Ability to operate independently; manage multiple stakeholders across internal/external global business units.
- Strong interpersonal/leadership; team-based culture; strong communication (verbal/written).
- Excellent judgment and ability to prioritize and implement decisions.
- Working understanding of data science (digital data infrastructure, visualization, statistical analysis).
- Knowledge of current GMP, ICH Guidelines, FDA QSR, EU MDR; familiarity with FDA/EMA/MHRA registration processes.
- Specialization in regulations/ISO standards and global device/combination product regulations (21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971).
- Knowledge of injection mould tooling design/processing; device polymers/materials engineering; springs/wire forming; device testing & lab management; mathematical modelling; automated device assembly techniques.
Benefits (if location-specific):
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary range $142,725–$237,875; annual bonus; eligibility for share-based long-term incentive. Benefits include health care and other insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.
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; represent MSAT at supplier technical and project meetings.
- Deliver robust supply strategy for the Device platform by collaborating with Strategy, Procurement, Quality, Logistics, etc., including mould tool & assembly asset validation programs.
- Lifecycle manage the Device Platform; drive Technology Transfer from R&D; manage post-approval regulatory changes, continued process verification, and manufacturing efficiency/COG reduction.
- Ensure global device/component manufacturing processes are capable, efficient, and meet specification.
- Own and maintain Device design including regulatory DHF/Technical file requirements; standardize global device supply; maintain compliance with procedures and external standards (e.g., FDA 21 CFR 820, (EU) 2017/745, MDR, ISO 13485, ISO 14971, ISO 10993).
- Support Device Director, Device Strategy, and Device Procurement on Continuous Improvement and Business projects within Global Supply Chain to deliver MSAT objectives.
- Cross-functionally communicate technical device challenges/successes to ensure technical and commercial success of drug delivery devices and integral combination products.
- Drive innovation via new device technologies/ways of working; champion business cases for sustainable manufacturing technology implementation (quality by design, design for manufacturing, design control, digital data management, analytical competency).
- Perform and lead risk management activities (e.g., risk file review/approval) as required as “risk owner.”
Basic qualifications:
- Bachelor’s in engineering or a Science Degree (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 in Medical Device/pharmaceutical Manufacturing environment.
- 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 activities and R&D processes for product development, NPS, and Technology Transfer.
- Understanding to manage device assembly, metrology & plastics testing techniques/procedures and specification/drawing systems.
- Experience leading device groups in a global matrix with successful global asset lifecycle management.
- Ability to operate independently; manage multiple stakeholders across internal/external global business units.
- Strong interpersonal/leadership; team-based culture; strong communication (verbal/written).
- Excellent judgment and ability to prioritize and implement decisions.
- Working understanding of data science (digital data infrastructure, visualization, statistical analysis).
- Knowledge of current GMP, ICH Guidelines, FDA QSR, EU MDR; familiarity with FDA/EMA/MHRA registration processes.
- Specialization in regulations/ISO standards and global device/combination product regulations (21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971).
- Knowledge of injection mould tooling design/processing; device polymers/materials engineering; springs/wire forming; device testing & lab management; mathematical modelling; automated device assembly techniques.
Benefits (if location-specific):
- If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary range $142,725–$237,875; annual bonus; eligibility for share-based long-term incentive. Benefits include health care and other insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.