Job Application for Director, Clinical Quality Assurance at Braeburn

Reports to: Senior Vice President, Technical Operations

Location: Remote or Plymouth Meeting, PA (Hybrid)

Company Overview:

Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At Braeburn, we challenge the status quo and champion transformation of the management of opioid use disorder (OUD) by partnering with the community to create a world where every person with OUD gets the best possible care and opportunity to reach their full potential. Our shared commitment to innovation on behalf of patients enables us to help people with OUD begin and sustain recovery.

At Braeburn, there are opportunities to contribute to our purpose every day. We value authenticity and strive to amplify all voices. Our culture empowers everyone to be successful and unleashes our full potential.

Position Summary:

The Director of Clinical Quality Assurance (CQA) is responsible for developing, implementing, and maintaining the company’s Clinical Quality Management System (QMS) to ensure compliance with Good Clinical Practices (GCP) regulatory requirements and industry standards. This role provides oversight of all third-party vendors involved in clinical development, including CROs, laboratories, and suppliers, ensuring adherence to Good Clinical Practice (GCP) and inspection readiness for regulatory agencies.

This role partners closely with Clinical Operations and Medical Affairs leadership to ensure clinical trial execution, oversight, and medical activities are conducted in compliance with GCP, regulatory expectations, and internal quality standards.

Specific Duties:

Quality Management System

Leads all Clinical Quality Assurance (QA) activities within the company
Develops, implements, and maintains all clinical quality assurance systems, processes, and procedures
Develops and tracks clinical quality metrics, approves all deviations, and develops Corrective and Preventative Actions (CAPAs)
Lead management review meetings and ensure continuous improvement.
Maintain inspection readiness for sponsor and regulatory inspections (FDA, EMA).

Quality Oversight of CROs and Vendors

Qualifies and audit CROs and clinical suppliers per internal SOPs.
Monitors CRO performance and ensures compliance with GCP and company standards.
Reviews CRO documentation (e.g., SOPs, TMF, risk management plans) for adequacy.

Risk and Compliance

Implements proactive risk identification and mitigation processes.
Coordinates clinical site audits and ensure timely resolution of findings.
Ensures compliance with ICH guidelines, FDA regulations, and Part 11 requirements.

Training and Communication

Build and roll out QA training programs for internal staff and CRO partners.
Serve as the primary QA contact for clinical teams and external partners.

Skills:

Established GCP QA professional
Robust understanding of quality management systems and GxP to ensure compliance with regulatory requirements
Excellent critical data analysis, written, and oral communication skills
Strong experience in QA Audits of Clinical sites and Third-party organizations
Demonstrated ability to successfully interact with regulatory health authorities at inspections as well as lead all preparation, hosting, and follow-up activities
Ability to lead and influence cross functional employees to ensure compliance, and able to enhance team performance through strong collaboration skills
Robust knowledge of successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring, SOPs, training, etc.

Education/Experience:

BA/BS in related field with at least 10 years of Quality Assurance experience in pharmaceutical GCP operations or related quality technical role in the medical space
Deep knowledge of international guidelines ICH-GCP as well as relevant local regulations
Significant experience with QA review of Clinical Protocols, CAPA reports, SOPs, change control processes, deviation/investigation reports, computer systems validation, QA agreements, audit reports
Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes
Demonstrated expertise in leading organizational and planning activities

Braeburn is committed to ensuring equal employment opportunity for all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, military/veteran status, age, disability, or any other category/characteristic protected by law (collectively, "Protected Categories"). In fact, we encourage all underrepresented backgrounds to apply for any open job positions with the company.

Braeburn Job Scam Warning

At Braeburn, we prioritize the security of your personal information. Be aware of individuals falsely presenting themselves as Braeburn employees or representatives to gain access to your personal information or money through fictitious job offers.

Braeburn will never ask for financial information or payment during the job application process. This includes but it is not limited to requests for bank account details, social security numbers, credit card numbers, or any form of payment for application fees, equipment, or software. Any claims that you will be reimbursed for such expenses are fraudulent.

We also will not ask you to download third-party applications for communication regarding job opportunities. Be cautious of offers from unofficial email addresses (e.g., Yahoo, Gmail, Hotmail) or those with misspelled variations of official Braeburn email addresses.

To ensure you are communicating about a legitimate job opportunity, check that the job is posted on Braeburn’s official career website. If you suspect you have been contacted about a fraudulent position, please contact Braeburn directly through our official channels at info@braeburnrx.com.

Braeburn is not liable for losses resulting from job recruiting scams. If you believe you are a victim of fraud, contact the FBI through the Internet Crime Complaint Center at https://www.ic3.gov or your local authorities.

Braeburn does not accept unsolicited assistance from search firms for employment opportunities. Resumes submitted without a valid written search agreement will be considered Braeburn's sole property, and no fee will be paid.

Create a Job Alert

Interested in building your career at Braeburn ? Get future opportunities sent straight to your email.

First Name

Last Name

Country

Phone

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

School

Select...

Degree

Select...

Discipline

Select...

Current Address (Full address)

Date Available for Employment

Do you have any friends or relatives employed by Braeburn?

Select...

Employee's Name (Referral)

(Use N/A if not applicable)

Current Company

Desired Base Salary ($)

Years of Biotech/Pharmaceuticals Experience

Select...

Years of Quality Assurance experience in pharmaceutical GCP operations

Select...

Are you at least 18 years old?

Select...

Are you an American citizen, lawful permanent resident of the United States, temporary resident, refugee or asylee?

Select...

Are you presently authorized to work for Braeburn in the position for which you are applying?

Select...

Will you now or in the future require Braeburn to sponsor you or to obtain, maintain or extend your employment authorization?

Select...

Are you related to any officer or member of the Board of Directors at Braeburn?

Select...

Are you able to perform the essential functions of the job for which you are applying, either with or without reasonable accommodations?

Select...

If no, please describe the functions that cannot be performed?

Has your professional license/certification/privilege ever been revoked or suspended (Yes, No, N/A)? If yes, state the reason(s).

Have you ever been involuntarily terminated from employment?

Specify foreign language proficiency (if relevant to position)

Please list three professional references from your last seven years of employment

LinkedIn Profile

Any additional comments

I understand that completion of this application does not obligate Braeburn to hire me or offer me employment. I certify that my answers are true, accurate, and complete to the best of my knowledge, I understand that any falsification, misrepresentation, or omission of any facts in my application, resume, or any other accompanying or required material, or during any interviews, can be justification for refusal of employment, or immediate termination of employment, regardless of when and how discovered. I understand that this employment application is not a contract of employment. I understand that, if employed, my employment may be terminated with or without cause, and with or without notice, at any time, at the option of either Braeburn or me. I understand that any oral or written statement to the contrary are hereby expressly disavowed and should not be relied upon by any prospective or existing employee. If hired, I agree to comply with all applicable laws and abide by the rules and regulations of Braeburn as issued from time to time. Braeburn may, at its sole discretion, hold in abeyance or revoke, amend or modify, abridge or change any benefit, policy, practice, condition or process affecting its employees. Any offer of employment I may receive from Braeburn is contingent upon my successful completion of the Company’s pre-employment screening process, including the receipt by Braeburn of references that it considers satisfactory. I authorize all of my former employers and those individuals I have listed as professional references to furnish information about my employment, work performance, abilities, and other qualities pertinent to my qualifications for employment, hereby releasing them from any and all liabilities for damages arising from furnishing the requested information. I also affirm that I have not signed any kind of restrictive document creating any obligation to any former employer that would restrict my acceptance of employment with Braeburn in the position I am seeking. I acknowledge that I have read and understand all of the above statements.

Select...

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 Braeburn ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Select...

Are you Hispanic/Latino?

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 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.

Veteran Status

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, 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?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

Select...

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.

Director, Clinical Quality Assurance

Apply for this job

Voluntary Self-Identification

Voluntary Self-Identification of Disability