Vacancy expired!
Quality Specialist– Commercial Quality· Master’s degree and 3 years of quality experience – combination products/pharma/medical device industryOR· Bachelor’s degree and 5 years of quality experience - combination products/pharma/medical device industry· Deep and broad understanding of quality processes including Deviation/CAPA, change control, design controls, risk assessment and management, and root cause analysis.· Combination product knowledge and understanding including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter design controls· Knowledge of quality engineering and device engineering· Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics· Strong problem solving, trouble shooting, and analytical skills· Advanced technical writing skills· Able to innovate in a highly regulated environment· Ability to work effectively in global cross-functional teams and in a highly matrixed team environment· Able to overcome uncertainty or ambiguity to achieve goals· Able to drive changes that lead to increases in efficiency leveraging strong cross-functional relationships· Excellent verbal and written communication· Lead and motivate a team· Ability to drive continuous improvements· Technical writing skills· Critical thinking skills· Possesses a global mindset· Provide oversight and SME support of the Deviation/CAPA process and ensure compliance to the procedures.· Own or provide Quality oversight of Deviation and CAPA and EV records, with attention to detail, review for completeness, accuracy and timeliness.· Conduct root cause analysis and problem-solving methodologies as necessary, facilitate proactive and effective resolution of issues.· Facilitate cross functional CAPA Board forums to enable systematic monitoring and execution of the process.· Generate and Monitor site Deviation/CAPA KPI’s, trend data on a periodic basis and document reports as required.· Working knowledge of design controls, risk management, complaints investigations, document management and other QMS.· Identify and participate in opportunities for improvement in creating an efficient, robust process.· 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)· Bachelor’s Degree in a Science Field· Ability to oversee multiple medium complexity projects simultaneously· Working knowledge of quality engineering and/or mechanical engineering· Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820.30,100, 210 and 211)· Prior experience working as part of a combination product commercial team· Able to successfully manage workload to timelines· Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources· Ability to operate in a cross functional team environment with site, functional area, and executive leadership· Experience driving decision making· Understanding of industry requirements/expectations of a QMS· Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)· Knowledge of technical standards, internal requirements, and regulations· Comfortable with both drug and device terminology· Ability to travel +/- 15-20% of time to domestic and international sites · Provide oversight and SME support of the Deviation/CAPA process and ensure compliance to the procedures.· Own or provide Quality oversight of Deviation and CAPA and EV records, with attention to detail, review for completeness, accuracy and timeliness.· Conduct root cause analysis and problem-solving methodologies as necessary, facilitate proactive and effective resolution of issues.· Facilitate cross functional CAPA Board forums to enable systematic monitoring and execution of the process.· Generate and Monitor site Deviation/CAPA KPI’s, trend data on a periodic basis and document reports as required.· Working knowledge of design controls, risk management, complaints investigations, document management and other QMS.· Identify and participate in opportunities for improvement in creating an efficient, robust process.· 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)· Bachelor’s Degree in a Science Field· Ability to oversee multiple medium complexity projects simultaneously· Working knowledge of quality engineering and/or mechanical engineering· Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820.30,100, 210 and 211)· Prior experience working as part of a combination product commercial team· Able to successfully manage workload to timelines· Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources· Ability to operate in a cross functional team environment with site, functional area, and executive leadership· Experience driving decision making· Understanding of industry requirements/expectations of a QMS· Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)· Knowledge of technical standards, internal requirements, and regulations· Comfortable with both drug and device terminology· Ability to travel +/- 15-20% of time to domestic and international sites
Vacancy expired!