Associate Director Vendor and Audit QSC
Associate Director Vendor and Audit QSC
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Job Description
How will your role help us transform hope into reality
Reporting to the Director of Quality Management Systems the Associate Director of Vendor and Audit Management will be primarily responsible for operational management of the GxP Vendor and Audit program supporting all clinical and commercial programs. You will have responsibility for managing a group ensuring that Blueprint and our vendors are in compliance with GxPs including the oversight of the GxP Master Vendor List and the implementation of effective tools for vendor evaluation selection qualification and requalification. You will use a riskbased approach to manage internal and external audit resources while maintaining the program on budget. Working collaboratively across Quality and with GxP vendor business owners across the organization you will maintain effective GxP Vendor Management and Audit Programs for the organization. The Associate Director of Vendor and Audit Management is accountable for ensuring that outsourced third parties are audited and in compliance according to services provided and will work to continuously support the improvement of internal regulated processes to support the state of GxP compliance at Blueprint Medicines.
What will you do
- Manage a team of FTEs and contractors to oversee the GxP Vendor and Audit and Inspection logistics programs the GxP Health Authority regulated areas.
- Design implement and oversee the continuous improvement of the vendor management and internal audit program procedures and processes supporting the companys global strategy
- Coordinate and manage all aspects of internal and vendor audit lifecycle: working with internal Quality and area management and consultants to schedule plan and track the reporting responses and closure of audits.
- Implement internal and external audit plans based on established procedures and corporate and Quality compliance prioritizations
- Coordinate schedule and prioritize GxP audits for contract manufacturers testing laboratories clinical research organizations external partners etc.
- Develop excellent working relationships with the crossfunctional quality team GxP business partners vendors and other functions
- Monitor global audit trends and work with the Director of Quality Management Systems and Quality area leads to inform of emerging areas of risk and regulations for incorporation into audit planning and .
- Manage and oversee US and Global regulatory inspection logistics and lead preparations for and in support of preapproval and routine regulatory agency inspections
- Participate in short and longrange planning of Vendor and Audit related activities planning resourcing and budgeting
- Develop and report meaningful quality metrics for monthly senior management and Quality Management Review reporting
- Identify opportunities to enhance continuous improvement and sustainable compliance for Vendors and Audits team through key performance indicators (KPIs)
- Identify compliance risks and escalate issues to management
- Evaluate the needs for standard operating procedures and systems to comply with regulatory agencies
- Hire train and develop a highly functioning team of diverse and inclusive personnel
- Manage staff and build processes that will drive innovation teamwork and efficiency within the organization
- Promote and advance a Quality Culture
- Travel domestically and internationally up to 2535
- Perform other responsibilities as assigned.
What minimum qualifications do we require
- Bachelors degree in chemistry biology engineering or related field or equivalent experience
- Minimum of 7 years of relevant experience in Biotechnology/Pharmaceutical industry
- 5 years experience in the management of Vendor and Audit Programs GMP QA/QC/Compliance in all phases with a focus on commercialization
What additional qualifications will make you a stronger candidate
- Demonstrated ability to lead both direct reports and in team environments
- Direct experience with Health Authority Inspections including PreApproval Inspections
- Excellent communication writing and presentation skills with both internal and external organizations
- Ability to assess complex issues and break down into viable solutions through risk management (FMEA PHA QRA etc)
- Demonstrated ability to lead and organize team meetings
- Ability to foster effective relationships with vendors and colleagues
- Familiar with the infrastructure and operational characteristics of manufacturing and clinical development vendors providing GxP services
- Practical knowledge of global GxPs and ability to make sound judgement and riskbased decisions
- Demonstrated ability to be agile flex resources and pivot effectively in response to shifting business priorities
- Strong project management experience: ability to manage multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure
- Commitment to our Core Values: Patients First Thoughtfulness Urgency Trust Optimism
Why Blueprint
At Blueprint Medicines we achieve impactful results because of our global crew of compassionate innovators the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights which drives our success.
This is the place where the extraordinary becomes reality and you could be part of it.
Patients are waiting. Are you ready to make the leap
Equity Diversity Inclusion and Affirmative Action
At Blueprint Medicines we foster a culture of equity diversity and inclusion. A proud Equal Employment Opportunity and Affirmative Action employer we consider all qualified applicants without regard to race color sex gender identity or expression sexual orientation age religion national origin ancestry ethnicity disability veteran status genetic information or any other characteristic protected under applicable law. We are also an EVerify Employer. We will make reasonable accommodations absent undue hardship for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process please reach out to
For more information please see ourEEOAA Policy Statement the EVerify Participation Poster the Right to Work Poster and/or theEEO Know Your Rights Poster as well as ourPay Transparency Statement.
Blueprint Medicines is a global fully integrated biopharmaceutical company that invents lifechanging medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research development and commercial capability and infrastructure we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria breast cancer and other solid tumors.
Required Experience:
Director
Employment Type
Full Time
