Merck Sharp & Dohme Corp.
Assoc. Dir., Quality Assurance, Contract Testing Labs CoE Lead
Merck Sharp & Dohme Corp., Rahway, New Jersey, us, 07065
Job DescriptionImportant details:Amount of travel:
25%
Please pay attention to the job posting locations; if you are from one of the indicated regions and you're selected as a finalist, you are expected to follow the local policies of work commuting.
Essential Responsibilities:Manages a team of Quality Assurance professionals as direct reports and complies with company requirements for People Managers (e.g., holds regular 1-on-1 for tactical and developmental discussions, executing objectives setting, mid-year and year-end reviews, etc.).
Accountable for the CTLs oversight involving samples management/testing of products with the assurance that the contracted services are in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations. This may include review of documentation and deviation investigations, ensure permanent inspections readiness, regulatory inspection support and monitoring, change control oversight and management, metric review, and review of annual product reviews. This also includes building effective quality systems at the CTLs and continuous improvement activities.
Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
Maintains and provides expertise on CTLs oversight systems, tools, data, and processes on an ongoing basis.
Contributes to the development of the CTLs Team budget and tracks and controls expenses as needed to meet budget. This includes Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
Must-Have Qualifications:Education:
Bachelor's College degree (or equivalent) in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
Experience:
Minimum of ten (10) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
Key leadership skills required for this role are networking and partnership, influence, ownership and accountability, decision making, coaching & development, motivation & inspiration and business savviness.
Communicates in English, both verbally and in writing.
Microsoft suite knowledge (Excel, PowerPoint, Word, Teams).
Preferred Experience and Skills:Analytical skills (QC Testing Techniques, strong laboratory practices, data integrity).
Previous experience or knowledge with Veeva Vault and SAP.
Power BI knowledge.
Prior management experience preferred.
Moderate level of contractual and financial awareness.
Previous experience participating in regulatory inspections.
Be conversant with all domestic and foreign regulations and compendia.
Current Employees apply
HERECurrent Contingent Workers apply
HEREEmployee Status:
RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:
HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:
11/22/2024*A job posting is effective until 11:59:59 PM on the day
BEFORE
the listed job posting end date. Please ensure you apply to a job posting no later than the day
BEFORE
the job posting end date.
Requisition ID:
R317871
#J-18808-Ljbffr
25%
Please pay attention to the job posting locations; if you are from one of the indicated regions and you're selected as a finalist, you are expected to follow the local policies of work commuting.
Essential Responsibilities:Manages a team of Quality Assurance professionals as direct reports and complies with company requirements for People Managers (e.g., holds regular 1-on-1 for tactical and developmental discussions, executing objectives setting, mid-year and year-end reviews, etc.).
Accountable for the CTLs oversight involving samples management/testing of products with the assurance that the contracted services are in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations. This may include review of documentation and deviation investigations, ensure permanent inspections readiness, regulatory inspection support and monitoring, change control oversight and management, metric review, and review of annual product reviews. This also includes building effective quality systems at the CTLs and continuous improvement activities.
Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
Maintains and provides expertise on CTLs oversight systems, tools, data, and processes on an ongoing basis.
Contributes to the development of the CTLs Team budget and tracks and controls expenses as needed to meet budget. This includes Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
Must-Have Qualifications:Education:
Bachelor's College degree (or equivalent) in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
Experience:
Minimum of ten (10) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
Key leadership skills required for this role are networking and partnership, influence, ownership and accountability, decision making, coaching & development, motivation & inspiration and business savviness.
Communicates in English, both verbally and in writing.
Microsoft suite knowledge (Excel, PowerPoint, Word, Teams).
Preferred Experience and Skills:Analytical skills (QC Testing Techniques, strong laboratory practices, data integrity).
Previous experience or knowledge with Veeva Vault and SAP.
Power BI knowledge.
Prior management experience preferred.
Moderate level of contractual and financial awareness.
Previous experience participating in regulatory inspections.
Be conversant with all domestic and foreign regulations and compendia.
Current Employees apply
HERECurrent Contingent Workers apply
HEREEmployee Status:
RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:
HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:
11/22/2024*A job posting is effective until 11:59:59 PM on the day
BEFORE
the listed job posting end date. Please ensure you apply to a job posting no later than the day
BEFORE
the job posting end date.
Requisition ID:
R317871
#J-18808-Ljbffr