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Executive Director - GMP Quality Assurance

Pharmaceutical Product Development (PPD)

US-WI-Middleton-Middleton WI Research Way

The PPD GMP Laboratories business unit of PPD is a market leader in providing GMP analytical services to the pharmaceutical, biotechnology, and medical device industries. The PPD GMP Laboratories have ~1,400 employees located in Middleton, Wisconsin and Athlone, Ireland. This is an exciting opportunity to join a rapidly growing scientific service business within one of the world’s premier drug development companies.

We provide a full complement of state-of-the-art GMP analytical testing resources and expertise to support commercial stability studies, release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms and delivery systems.

As theExecutive Director QA(GMP), your basic purpose will be to ensure efficient and effective management of PPD resources. You will supervise and assist group leaders and scientists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. In addition, you will plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. You will assist the division director in strategic planning, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.

Responsibilities: Manages staff and quality assurance initiatives in PPD global laboratory locations. Role includes focus on GlobalGMP lab QA operations. Assigns work and reviews workload for all direct reports. Establishes goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. Recommends and approves courses of action on all management / human resources’ matters. ·Develops and executes GxP compliance strategies and establishes quality and compliance standards and matrices for PPD's clinical research operational units ·Analyzes compliance/quality matrix data, notifies senior management of critical compliance nonconformance Takes leadership role with peers in operational units to proactively identify issues impacting the quality and/or integrity of clinical research and/or laboratory programs, determines root cause of nonconformance, and develops effective problem solution strategies Provides strategic and tactical direction to staff for assigned department(s) in execution of departmental objectives Hires, develops, and mentors staff to expand organizations capability and ensure effective management of QA staff Manages contracts to ensure contractual obligations and business requirements are met ·Serves as Senior Advisor to peers, teams, and clients on the interpretation and implementation of current FDA and International GxP and computer validation trends and requirements ·Assesses impact of client and regulatory observations of data integrity and overall quality management and provides recommendation for corrective action to the respective teams ·Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences ·Fosters client relationships and provides strategic guidance on quality business initiatives. Provides regulatory support for clients as needed for addressing regulatory concerns such as validation issues and agency questions as needed ·Maintains leadership role through active participation in leadership team meetings, presentations to site staff on compliance and quality issues Develops and maintains applicable quality and site metrics. Participates on site quality and business process improvement issues Handles delegated tasks and responsibility as requested by senior leadership. Represents QA at client audits and regulatory authority inspections

Peptide synthesis - classical & SPPS, netropsin group antibiotics synthesis and modification, general synthetic organic chemistry, synthetic organic matter purification, characterization, lyophilization. Small molecule synthesis, drug-DNA interaction, general chemical laboratory safety skills.

Chromatography – TLC, gravity, HPLC, UHPLC - GPC, distribution, flash, RP-HPLC, HILIC, chiral, SEC, multi-mode, multiple detection techniques - UV-vis, DAD, CAD, ELS, RI, OR, EC, GC-FID, GC-MS; safe operating, method development.

Capillary electrophoresis – Beckman P/ACE.

Mass-spectrometry – ESI & APCI interfaced single and triple quads (Agilent, ABI-SCIEX, Waters), TOF (Agilent, Bruker), ion-trap (Extrel FTMS); LC-MS, LC-MS/MS, GC-MS. Peptide mapping by LC-MS/MS.

MassChrom, ChemStation, MassHunter, LabSolutions, Analyst.

Early ADME - chemical stability, logD, solubility, metabolic stability, metabolite identification.

Developing HT methods of QC/QA for chemical combinatorial libraries.

Automating data collection, handling, processing, reporting. MS Outlook, Excel, VB for Excel, Word, Virscidian Analytical Studio.

Operating, maintaining & PM of HPLC and MS instrumentation from Shimadzu, Agilent, Waters, Gilson, ABI-SCIEX, PE.

#PPDLABS

#LI-33456501_TG1

The PPD GMP Laboratories business unit of PPD is a market leader in providing GMP analytical services to the pharmaceutical, biotechnology, and medical device industries. The PPD GMP Laboratories have ~1,400 employees located in Middleton, Wisconsin and Athlone, Ireland. This is an exciting opportunity to join a rapidly growing scientific service business within one of the world’s premier drug development companies.

We provide a full complement of state-of-the-art GMP analytical testing resources and expertise to support commercial stability studies, release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms and delivery systems.

As theExecutive Director QA(GMP), your basic purpose will be to ensure efficient and effective management of PPD resources. You will supervise and assist group leaders and scientists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. In addition, you will plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. You will assist the division director in strategic planning, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.

Responsibilities: Manages staff and quality assurance initiatives in PPD global laboratory locations. Role includes focus on GlobalGMP lab QA operations. Assigns work and reviews workload for all direct reports. Establishes goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. Recommends and approves courses of action on all management / human resources’ matters. ·Develops and executes GxP compliance strategies and establishes quality and compliance standards and matrices for PPD's clinical research operational units ·Analyzes compliance/quality matrix data, notifies senior management of critical compliance nonconformance Takes leadership role with peers in operational units to proactively identify issues impacting the quality and/or integrity of clinical research and/or laboratory programs, determines root cause of nonconformance, and develops effective problem solution strategies Provides strategic and tactical direction to staff for assigned department(s) in execution of departmental objectives Hires, develops, and mentors staff to expand organizations capability and ensure effective management of QA staff Manages contracts to ensure contractual obligations and business requirements are met ·Serves as Senior Advisor to peers, teams, and clients on the interpretation and implementation of current FDA and International GxP and computer validation trends and requirements ·Assesses impact of client and regulatory observations of data integrity and overall quality management and provides recommendation for corrective action to the respective teams ·Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences ·Fosters client relationships and provides strategic guidance on quality business initiatives. Provides regulatory support for clients as needed for addressing regulatory concerns such as validation issues and agency questions as needed ·Maintains leadership role through active participation in leadership team meetings, presentations to site staff on compliance and quality issues Develops and maintains applicable quality and site metrics. Participates on site quality and business process improvement issues Handles delegated tasks and responsibility as requested by senior leadership. Represents QA at client audits and regulatory authority inspections

Peptide synthesis - classical & SPPS, netropsin group antibiotics synthesis and modification, general synthetic organic chemistry, synthetic organic matter purification, characterization, lyophilization. Small molecule synthesis, drug-DNA interaction, general chemical laboratory safety skills.

Chromatography – TLC, gravity, HPLC, UHPLC - GPC, distribution, flash, RP-HPLC, HILIC, chiral, SEC, multi-mode, multiple detection techniques - UV-vis, DAD, CAD, ELS, RI, OR, EC, GC-FID, GC-MS; safe operating, method development.

Capillary electrophoresis – Beckman P/ACE.

Mass-spectrometry – ESI & APCI interfaced single and triple quads (Agilent, ABI-SCIEX, Waters), TOF (Agilent, Bruker), ion-trap (Extrel FTMS); LC-MS, LC-MS/MS, GC-MS. Peptide mapping by LC-MS/MS.

MassChrom, ChemStation, MassHunter, LabSolutions, Analyst.

Early ADME - chemical stability, logD, solubility, metabolic stability, metabolite identification.

Developing HT methods of QC/QA for chemical combinatorial libraries.

Automating data collection, handling, processing, reporting. MS Outlook, Excel, VB for Excel, Word, Virscidian Analytical Studio.

Operating, maintaining & PM of HPLC and MS instrumentation from Shimadzu, Agilent, Waters, Gilson, ABI-SCIEX, PE.

#PPDLABS

#LI-33456501_TG1

Education and Experience:

Bachelor's degree required.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 to 15 years) or equivalent and relevant combination of education, training, and experience. 5 to 10 years of management responsibility.

Knowledge, Skills and Abilities:

Excellent knowledge of Quality Assurance methods

Thorough knowledge of GMP regulations and compliance

Risk based auditing knowledge

Strong data integrity experience

Strong management and leadership skills

Demonstrated ability to collaborate and align QA with operations

Excellent oral and written communication skills

Experience in writing and reviewing Standard Operating Procedures

Strong problem solving, risk assessment and impact analysis abilities

Solid experience in root cause analysis Solid experience in CAPA review

Demonstrated experience in process improvement

Strong negotiation and conflict management skills

Familiar with QA information management systems and Laboratory Information Management systems

Flexible and able to multi-task and prioritize competing demands/work load

Ability to think independently and influence when appropriate

PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.

Education and Experience:

Bachelor's degree required.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 to 15 years) or equivalent and relevant combination of education, training, and experience. 5 to 10 years of management responsibility.

Knowledge, Skills and Abilities:

Excellent knowledge of Quality Assurance methods

Thorough knowledge of GMP regulations and compliance

Risk based auditing knowledge

Strong data integrity experience

Strong management and leadership skills

Demonstrated ability to collaborate and align QA with operations

Excellent oral and written communication skills

Experience in writing and reviewing Standard Operating Procedures

Strong problem solving, risk assessment and impact analysis abilities

Solid experience in root cause analysis Solid experience in CAPA review

Demonstrated experience in process improvement

Strong negotiation and conflict management skills

Familiar with QA information management systems and Laboratory Information Management systems

Flexible and able to multi-task and prioritize competing demands/work load

Ability to think independently and influence when appropriate

PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.

Job posted: 2021-04-01

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