Regulatory Compliance Data Integrity Specialist, Senior

About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visitwww.agcbio.com. 

Job Summary

The 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.

Position is located at both Boulder and Longmont, Colorado facilities.

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 oversite 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 oversite 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 RANGE:

$94,000 - $129,250

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

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.