Regulatory Compliance Specialist, Senior

AGC Biologics

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, on time. For more information, visit www.agcbio.com. 

 

JOB SUMMARY 

The primary responsibilities for this role includes creating, implementing and maintaining the site inspection management and readiness programs supporting development and commercial drug substance-manufacturing sitesThis position is also responsible for internal audits and risk managementWorks on moderate to highly complex problems where analysis of situations or data requires an in-depth evaluation of various factorsThis role requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with people who might be junior or senior to the incumbent.   The successful candidate is able to work under minimal direction and possesses the ability to work on complex problems by analyzing procedures and data to create appropriate solutions. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

  • Create, revise and implement quality system documents for the internal audit program, annual product reviews, compliant handling, recalls, quality risk management and Site Master File Complete site procedure gap assessments to corporate policies. 

  • Support various quality systems through assessment of change control for regulatory and filing impact; review of new product introduction; assignment of product part numbers; provision of regulatory intelligence on suppliers; and reporting of audit, complaint/recall and Quality Risk Management (QRM) metrics to Quality Management Review. 

  • Implement, maintain and improve the Inspection Management Program by using and maturing inspection management tools and providing and improving on going site training for audit interactions. 

  • Implement, maintain and improve the Inspection Readiness program.  Review documents and systems to identify key area of compliance risk and work with system owners to create position papers as needed. 

  • Participate in regulatory and client audits by serving as a back room manager, runner, scribe, assembler or request verifier and strategy prepper.  

  • Create and manage the internal audit scheduleExecute internal audits according to the schedule to ensure execution of quality systems comply with regulation and AGC proceduresPrepare audit agendas and audit reports; track audit responses. 

  • Provide oversite and guidance of the Quality Risk Management (QRM) programEnsure QRM tools are appropriately utilized to assess, control, communicate and review risks across quality systems and of manufactured product across the product lifecycle.  

  • Support client interactions by: 

  • Assisting with completion of client quality questionnaires 

  • Facilitating cross-functional review of client quality agreements 

  • Assisting with complaint and recall management 

  • Support data collection for Annual Product Quality Reviews 

  • This position is a delegate for other Regulatory Compliance Specialists and may be a delegate for Director Regulatory Compliance. 

 

KNOWLEDGE, SKILLS, AND 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.  
  • 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 applicationsProficiency 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. 

 

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 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 Dependent on experience 

 

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.

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