Manager – Senior Manager, Quality Systems and Compliance
Job Title: Associate Director, Quality Systems and Compliance
Company: Biopharma
Location: Remote, US
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
We work with a range of life sciences organizations across multiple industry disciplines, with one of our strongest portfolio’s in Quality Systems. With US offices strategically located on the east coast (DC Metro) and west coast (San Diego) we connect rare life sciences talent with emerging companies nationwide.
Position Overview: Quality Systems and Compliance (Associate Director)
The Associate Director of Quality Systems & Compliance will manage and administer the infrastructure and elements of the QMS department ensuring a QMS quality unit that is compliant, effective, and agile to support a rapidly growing organization.
The candidate will provide quality administration for all elements of QMS, which includes: Change Control, Deviation Management, Corrective and Preventive Action, Training, and Document Control for all aspects including identification and escalation of quality system and product issues.
Additional Duties to include:
- Support maintenance of Quality Agreements with contract manufacturers, laboratories and consigned suppliers
- Author, review, and/or approve Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), and supporting documentation
- Leverage IT systems (e.g., Veeva) to assure compliant management and documentation of GxP Quality Systems processes
- Continuously improve and streamline Quality Systems processes (e.g., by developing new tools, removing non-value adding activities, automating manual steps)
- Generate, track, and trend Quality Systems compliance metrics and compile metrics and information to produce Quality Management Team reports
- Serve as a Subject Matter Expert for GxP Quality System processes across organization
- Support internal and vendor audit program as needed
- Support FDA and marketing partners regarding quality issues, including field alerts, recalls and regulatory actions
- Support GMP inspections and audits by both regulatory authorities and notified bodies, and provide follow-up responses for all aspects of the business.
- Support the preparation of Quality Management Review meetings
Opportunity Highlights:
- Upcoming pivotal milestones and advancing late phases trials
- Hiring across all verticals in preparation for NDA submission
- Unlimited Professional Paid Time Off
- Annual Holiday Shutdown
- Competitive base, annual bonus, equity offerings!
- Wellness programs & Fitness reimbursement
- Paid Parental Leave
- Flexible working environment (Hybrid & Remote options)
Position Requirements:
- Bachelor’s degree in a scientific or technical discipline is required.
- A minimum of 8 years of experience in GxP and Quality Systems in biotechnology or pharmaceutical environment is required. (Must have clinical experience)
- Experience in implementing and managing electronic Quality Management Systems (Veeva Vault preferred)
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.
