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Director, Quality Assurance Operations

Company: AGC Biologics
Location: Boulder
Posted on: September 12, 2020

Job Description:

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 .

SUMMARY:

The  Director of Quality Assurance (QA) Operations  is accountable for leading and managing the day-to-day activities of the QA Operations department. The position will help drive the development and management of the QA organization for a new Biologics facility. The site’s business objectives focus on advancing development products through commercialization and commercial manufacturing. The Director will be responsible for QA lot disposition, raw material release and provide QA support and oversight of manufacturing, facilities, and QC.

PRINCIPAL RESPONSIBILITIES

Supports development of policies, processes, procedures and controls ensuring that performance and quality of products conform to established cGMP standards and regulatory requirements

Develops, implements and maintains processes to support lot disposition and raw material disposition for clinical and commercial Biologics production

Manages QA support for the review and approval of documentation such as batch records, process and equipment validation protocols and reports, product specifications and change controls

Evaluates proposed process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory guidelines and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.

Provides expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance

Leads and supports investigations associated with major deviations in operations

Represents company in dealing with clients and supports implementation of Quality Agreements

Partners with Manufacturing and QC to enhance the GMP compliance profile of the site by ensuring the timely closure of investigations and implementation of appropriate corrective actions

Ensures that all trends are evaluated, that root causes are identified and corrective actions are implemented

Authors, reviews and / or approves internal quality documents (SOPs, deviations, CAPAs, change controls, etc.) and external regulatory agency documents

KNOWLEDGE, SKILLS & ABILITIES:

Ability to understand and apply GMP regulations as they relate to manufacturing, testing and facility operations

Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills

Strong interpersonal, written and oral communication skills

Strong problem-solving skills

Strong management, staff development and mentoring skills

EDUCATION / EXPERIENCE:

BS in Physical Sciences, Life Sciences or Engineering; advanced degree is preferred

15+ years of relevant experience in a biotechnology and GMP environment

Experience with QA and GMP compliance in clinical and commercial Biologics drug substance manufacturing

Equivalent education and experience may substitute for stated requirements

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.

U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at AGC Biologics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

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.

Gender Please select Are you Hispanic/Latino? Please select 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 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.

Veteran Status Please select 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

Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

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.

Keywords: AGC Biologics, Boulder , Director, Quality Assurance Operations, Other , Boulder, Colorado

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