Head, Experimental Medicine Quality (Oncology)
- Employer
- GSK
- Location
- Collegeville, Pennsylvania; Waltham, Massachusetts
- Salary
- Competitive
- Closing date
- Mar 5, 2021
View more
- Discipline
- Life Sciences, Oncology, Health Sciences, Medicine
- Job Type
- Academic Dean/Dept. Head
- Organization Type
- All Industry, Pharma
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The Oncology Experimental Medicine Unit (EMU) is seeking a Head, Experimental Medicine Quality. The EMU is responsible for Oncology's biomarker and diagnostics activities and requires a Head of Quality with expertise in regulated clinical laboratory activities and diagnostic development. Responsibilities will include establishing and managing a team of Quality professionals and oversight of the EMU Quality program. The successful candidate will work within the EMU and across departments to ensure clinical trial predictive diagnostic and other experimental medicine biomarker specimen acquisition, testing, results reporting, and archiving are compliant with all applicable regulations.
This position will be responsible for ensuring compliance across Oncology companion and complementary diagnostic projects. While the EMU is building robust processes to enable Quality upon initial project execution, a Quality function itself is required to ensure output matches expectations.
Key responsibilities
Requirements
Certification / training with any of the following:
GCP Certification
CAP/CLIA Certified
ISO 15189 Certification
21 CFR 820 Certification
21 CFR 11 Training
ISO 13485 Certification
CAP BAP Accreditation
HTA Submissions
GDPR Compliance
GCLP Training
Clinical Trials Directive / Clinical Trials Regulation
Regulations of Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA), National Medicinal Products Administration (NMPA)
Preferred Qualifications
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
This position will be responsible for ensuring compliance across Oncology companion and complementary diagnostic projects. While the EMU is building robust processes to enable Quality upon initial project execution, a Quality function itself is required to ensure output matches expectations.
Key responsibilities
- Build and manage a team of Quality personnel
- Manage EMU laboratory and related facility assessments
- Develop and monitor Quality metrics for EMU activities including clinical trial specimen management and clinical testing
- Manage the development of EMU SOPs, GUIs, other controlled documents in harmonization with GSK's Quality System
- Manage overall EMU Quality including specimen operations, clinical biomarker and diagnostic testing, sample bank
- Department training
- Identify, document, and model risks; with matrix team contribute to risk mitigation efforts
- Represent the Experimental Medicine Unit in cross organization Quality workstreams
- Maintain Quality aspects of service provider agreements
- Audit readiness at all times
- Other duties as assigned
Requirements
- BS/BSN/MS/PhD
- Position requires analytical skills, critical thinking, communication skills
- Direct experience working in a regulated diagnostics and /or clinical testing setting
- The Head of EMU Quality will need to be familiar with local regulations from across the globe to ensure testing compliance.
Certification / training with any of the following:
GCP Certification
CAP/CLIA Certified
ISO 15189 Certification
21 CFR 820 Certification
21 CFR 11 Training
ISO 13485 Certification
CAP BAP Accreditation
HTA Submissions
GDPR Compliance
GCLP Training
Clinical Trials Directive / Clinical Trials Regulation
Regulations of Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA), National Medicinal Products Administration (NMPA)
Preferred Qualifications
- Stem Nursing highly desirable
- Clinical Trials Directive / Clinical Trials Regulation
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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