AGC Biologics
Regulatory Compliance Data Integrity Senior Specialist
AGC Biologics, Boulder, Colorado, United States, 80301
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
One Colorado, one team.
At our Boulder and Longmont locations, we cultivate a unified team under the banner of 'One Colorado', fostering collaboration among diverse teams and their respective business units. Together, we leverage a shared services objective between the two sites to enhance care for our clients and their patients.
JOB SUMMARYThe primary responsibilities of this role include providing oversight of electronic data systems (e-systems, such as electronic spreadsheets, laboratory and manufacturing data systems, etc.) and paper systems used in support of GMP operations and establishing a site Data Integrity (DI) program. This includes ensuring the creation of procedures for computer systems validation activities and data integrity to ensure the principals are established and adhered to comply with applicable regulatory requirements and expectations (GXP, GAMP5, 21 CFR Part 11 (US) and EU Annex 11). This role is also responsible for promoting a culture of continuous improvement by monitoring key performance indicators (KPIs), DI risk assessments and identifying and/or driving other continuous improvement initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide guidance for implementation of site procedures regarding validation requirements for e-systems to ensure they comply with regulatory requirements for DI.
Ensure risk-based methodologies for the assessment of computer systems and evaluation of proposed changes to computer systems are established and provide oversight of execution.
Perform Internal Audits of computer systems validation and other DI activities, protocols and procedures and data integrity risk assessments.
Partner with the Corporate QA Data Integrity lead, participate in the DI Global Community, serve as the site DI subject matter expert (SME) and promote/train/coach sites staff on ALCOA+ principles and regulations.
Ensure the validation, implementation, change management of e-systems and data acquisition at the sites are conducted in compliance with GXP, GAMP5, 21 CFR Part 11 (US), EU Annex 11 and other international requirements.
Support implementation of technology-based solutions for processes used across the Quality Control, Facility and Manufacturing operations including systems such as QMS, LIMS, building management systems, manufacturing control systems and data acquisition systems.
Effectively partner with IT, Validation, QC, Engineering and other key stakeholders responsible for identifying, proposing, defining user requirements and implementing integrated electronic data systems to ensure a compliant management of the e-systems lifecycle.
Support the automation of data gathering, processing and information management in support of Quality compliance and operational KPI trending.
Drive continuous improvement to enhance productivity and efficiency of operations across the site.
Support as subject matter expert during regulatory inspections.
May participate in regulatory and client audits by serving as a host, back room manager, scribe or strategy prepper.
Provide oversight and guidance of the Quality Risk Management (QRM) program. Ensure QRM tools are appropriately utilized to assess, control, communicate and review risks across quality systems and of manufactured product across the product lifecycle.
KNOWLEDGE, SKILLS & ABILITIES:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Strong knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH Q7, ICH Q10, 21 CFR 210 and 211, 21 CFR Part 11, 21 CFR 600 and 610, EU Annex 11 and GAMP 5.
Proven technical writing skills. Proven ability to conduct risk assessments.
Proven ability to lead or co-lead audits. Skilled in regulatory inspection interactions (e.g. FDA).
Skill in verbal communications.
Ability to respond to complex inquiries or complaints from customers, co-workers and supervisors regarding products and processes.
Strong knowledge of quality processes and compliance.
Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications.
Proficiency with Microsoft applications, including MS Word, MS Excel and Teams preferred.
Skill in time and priority management. Must be able to work under general direction to complete work tasks.
Demonstrated ability to work collaboratively to accomplish deadlines and objectives. Exceptional skills in leadership, coaching, analytical problem solving and strong business acumen.
EDUCATION and/or EXPERIENCE
BS/BA in chemistry, biology, engineering or related life sciences field and 8+ years of experience in a Biotech/Pharmaceutical production environment; or Master’s Degree and 5+ Years of experience in a Biotech/Pharmaceutical production environment.
At least five (5) years of experience in quality operations (QA, QC, Quality Systems) or IT with demonstrated proficiency in the application of DI and Computer Systems.
At least three (3) years’ experience interacting with FDA or other regulatory agencies.
Three (3) years’ formal auditing (internal or supplier) experience preferred.
Experience interacting with clients in a Contract Development and Manufacturing Organization (CDMO) strongly preferred.
Compensation:$83,920.00 - $125,880.00
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
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One Colorado, one team.
At our Boulder and Longmont locations, we cultivate a unified team under the banner of 'One Colorado', fostering collaboration among diverse teams and their respective business units. Together, we leverage a shared services objective between the two sites to enhance care for our clients and their patients.
JOB SUMMARYThe primary responsibilities of this role include providing oversight of electronic data systems (e-systems, such as electronic spreadsheets, laboratory and manufacturing data systems, etc.) and paper systems used in support of GMP operations and establishing a site Data Integrity (DI) program. This includes ensuring the creation of procedures for computer systems validation activities and data integrity to ensure the principals are established and adhered to comply with applicable regulatory requirements and expectations (GXP, GAMP5, 21 CFR Part 11 (US) and EU Annex 11). This role is also responsible for promoting a culture of continuous improvement by monitoring key performance indicators (KPIs), DI risk assessments and identifying and/or driving other continuous improvement initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide guidance for implementation of site procedures regarding validation requirements for e-systems to ensure they comply with regulatory requirements for DI.
Ensure risk-based methodologies for the assessment of computer systems and evaluation of proposed changes to computer systems are established and provide oversight of execution.
Perform Internal Audits of computer systems validation and other DI activities, protocols and procedures and data integrity risk assessments.
Partner with the Corporate QA Data Integrity lead, participate in the DI Global Community, serve as the site DI subject matter expert (SME) and promote/train/coach sites staff on ALCOA+ principles and regulations.
Ensure the validation, implementation, change management of e-systems and data acquisition at the sites are conducted in compliance with GXP, GAMP5, 21 CFR Part 11 (US), EU Annex 11 and other international requirements.
Support implementation of technology-based solutions for processes used across the Quality Control, Facility and Manufacturing operations including systems such as QMS, LIMS, building management systems, manufacturing control systems and data acquisition systems.
Effectively partner with IT, Validation, QC, Engineering and other key stakeholders responsible for identifying, proposing, defining user requirements and implementing integrated electronic data systems to ensure a compliant management of the e-systems lifecycle.
Support the automation of data gathering, processing and information management in support of Quality compliance and operational KPI trending.
Drive continuous improvement to enhance productivity and efficiency of operations across the site.
Support as subject matter expert during regulatory inspections.
May participate in regulatory and client audits by serving as a host, back room manager, scribe or strategy prepper.
Provide oversight and guidance of the Quality Risk Management (QRM) program. Ensure QRM tools are appropriately utilized to assess, control, communicate and review risks across quality systems and of manufactured product across the product lifecycle.
KNOWLEDGE, SKILLS & ABILITIES:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Strong knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH Q7, ICH Q10, 21 CFR 210 and 211, 21 CFR Part 11, 21 CFR 600 and 610, EU Annex 11 and GAMP 5.
Proven technical writing skills. Proven ability to conduct risk assessments.
Proven ability to lead or co-lead audits. Skilled in regulatory inspection interactions (e.g. FDA).
Skill in verbal communications.
Ability to respond to complex inquiries or complaints from customers, co-workers and supervisors regarding products and processes.
Strong knowledge of quality processes and compliance.
Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications.
Proficiency with Microsoft applications, including MS Word, MS Excel and Teams preferred.
Skill in time and priority management. Must be able to work under general direction to complete work tasks.
Demonstrated ability to work collaboratively to accomplish deadlines and objectives. Exceptional skills in leadership, coaching, analytical problem solving and strong business acumen.
EDUCATION and/or EXPERIENCE
BS/BA in chemistry, biology, engineering or related life sciences field and 8+ years of experience in a Biotech/Pharmaceutical production environment; or Master’s Degree and 5+ Years of experience in a Biotech/Pharmaceutical production environment.
At least five (5) years of experience in quality operations (QA, QC, Quality Systems) or IT with demonstrated proficiency in the application of DI and Computer Systems.
At least three (3) years’ experience interacting with FDA or other regulatory agencies.
Three (3) years’ formal auditing (internal or supplier) experience preferred.
Experience interacting with clients in a Contract Development and Manufacturing Organization (CDMO) strongly preferred.
Compensation:$83,920.00 - $125,880.00
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
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