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 and cell and gene therapies. 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.

 

SUMMARY:

The Seattle Director of Regulatory Compliance is responsible for the development of a site infrastructure for management of inspections, internal and external audits consistent with Global Policies, SOPs and Guidelines. They will lead activities supporting operational alignment for remediation of the areas of highest compliance risk, communicate across site functions and is a key contributor to the development of behaviors and practices that foster a culture of constant inspection readiness.

 

PRINCIPAL RESPONSIBILITIES:

  • Provide leadership and vision to drive a quality culture by developing and implementing an inspectional preparation strategy aligned to business goals to achieve positive results for the organization
  • Implement key inspectional/audit processes such as compliance risk assessment, presenter preparation, logistical infrastructure, inspection staff training program and a talent management program for inspection/audit speakers & logistical support staff
  • Facilitate alignment of local program with global requirements
  • Implement and lead internal and client audits
  • Drive collaboration across site functions to remediate top compliance risks and engage in cross-functional planning to leverage resources to improve speed of resolution
  • Partner with peers at the operational sites to share and adopt best practices across the network to drive continuous improvement
  • Routinely interface with internal and external auditors to coordinate site inspections/audits
  • Routinely present information to senior management related to site preparation status, needed resources and/or roadblocks
  • Responsible for obtaining and renewing required regulatory/compliance site licenses
  • Own site self-inspection program
  • Responsible for completion of Quality Agreements with external clients

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Technical expertise in regulatory requirements across multiple jurisdictions which enables of assessment of compliance risk
  • Deep knowledge in the techniques used by auditors/inspectors to judge compliance level of the site
  • Skilled in strategic thinking, managing through systems, communication and negotiation
  • Actively develops and maintains strong professional relationships building trust and respect across the organization
  • Lead through influence, effectively build alignment and collaborate with multiple stakeholders
  • Assess performance roadblocks and develop appropriate solutions
  • Willing to have difficult conversations, meetings, and make decisions related to readiness of areas for inspection
  • Facilitate organizational change related to quality systems across multiple functions

 

EDUCATION/EXPERIENCE:

  • Bachelor’s degree in scientific or regulatory area
  • A minimum of 10+ years’ experience required
  • Direct experience leading or supporting multiple functions in a pharmaceutical, biotech or a regulatory industry is requires
  • Direct Experience hosting and/or leading Regulatory Inspections, Audits and continuous improvement projects
  • Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated
  • Experience in protein therapeutics, cell gene therapy and/or viral vector manufacturing preferred

 

COMPENSATION RANGE:

$164,400 - $226,050 annually

 

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.
 
LI-LH1

Apply for this Job

* Required
resume chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
When autocomplete results are available use up and down arrows to review
+ Add another education

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in AGC Biologics ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.