Director, Commercial Operational GMP Quality (Hybrid)
Director, Commercial Operational GMP Quality (Hybrid)
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$ 176000 - 264000
1 Vacancy
Job Description
Job Description
General Summary:
The Director Commercial Operations GMP Quality role for Biologics and Combination Device Quality will be responsible to strategize plan implement execute and maintain global Quality Operational organization processes and compliance with global Biologics and Medical Devices regulations Guidance Documents and standards. The role will have hand on experience in working cross-functionally and with external partners in establishing effective and compliant processes and systems to maintain continuous level of regulatory compliance and successful outcome from regulatory inspections. The role will be responsible for working with internal and external stakeholders in a matrix environment Influencing/building/promoting a culture of Quality and to meet business quality and regulatory objectives.
Key Duties and Responsibilities:
Act as a Commercial Biologics and Device Subject Matter Expert (SME) for Vertexs Biologics and Combination Products.
Create Commercial Quality Operational Strategy for Biologics Programs leading implementing executing and maintaining organizational process and systems infrastructure.
Partners with internal Corporate Quality Manufacturing Supply Chain Distribution Quality and externally with Contract Manufacturing and Testing Labs for a successful compliant and effective commercial product launch globally.
Partner and lead regulatory pre-approval inspections and routing regulatory inspections to ensure successful outcome.
Quality oversight of product process analytical validation Technical Transfers and CMC product development activities.
Establishment Commercial Quality Agreements and maintain close oversight with external contract partners to ensure compliance with Quality Agreement and regulatory requirements.
Responsible for commercial Biologics Device QA Product Disposition and Release Change Control Supplier Corrective Actions Compliant Management Quality Management Reviews Annual Product Review Recall Management external partner oversight and many other quality management systems
Identify and communicate risks and assist with risk mitigation plans as necessary
Represent Biologics and Quality to lead/participate in complex project involving biologics and medical device and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
Lead/participate with cross-functional stakeholders in Biologics and Device Team with projects and improvements and associated mitigation plans to meet business Quality and regulatory objectives.
Provide necessary commercial quality support for global license application preparation.
Development and coaching of Staff
Knowledge and Skills:
Technical competency and knowledge on Biologics Drug Substance Drug Products Fill and Finish Analytical Testing Process Validation Analytical Test Validation and global biologics regulations and standards.
Technical knowledge on sterility Assurance Contamination Control Microbiology
Quality and Compliance Subject Matter Expert in Commercial Quality and Combination Devices
Analysis and other Operational Excellence experience such as LEAN DMAIC Six Sigma.
Ability to apply risk management principles to decision making and operational priorities
Excellent communication skills and a track record working in a matrix environment; Influencing/building/promoting a culture of Quality
Strong leadership through a partnership and engagement approach with manufacturing for advancing quality outcomes and operational excellence.
Subject Matter Expert in leading and hosting successful regulatory inspections.
Excellent track record in maintaining positive proactive and professional relationship and partnership with external partners.
Education and Experience:
B.S. in Science (Chemistry Biology Microbiology)
15 years of relevant work experience in commercial quality within Biologics including experience in launching biologics product globally
#hybrid
Pay Range:
$176000 - $264000Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:
In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at
Required Experience:
Director
Employment Type
Full-Time
