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Senior Director of Quality Assurance - Direct Hire

Remote: 
Full Remote
Contract: 
Full time
Salary: 
38 - 225K yearly
Experience: 
Senior (5-10 years)
Work from: 
United States

Offer summary

Qualifications:

Bachelor’s Degree., Experience in pharmaceutical processes and applications., Ability to lead cross-functional teams., Proficient in budget management., Understanding of FDA and global regulations..

Key responsabilities:

  • Develop QA vision and drive quality-first mindset.
  • Provide strategic guidance for Quality Assurance activities.
  • Oversee compliance with GxP, FDA, EMA regulations.
  • Conduct inspections and ensure readiness for regulatory audits.
  • Manage overall budget and talent acquisition for Quality Operations.
USDM Life Sciences logo
USDM Life Sciences SME https://usdm.com/
201 - 500 Employees
About USDM Life Sciences
How fast can a life sciences organization move with innovative information technology at the core of every action? What if routine, regulated tasks across departments and continents were automated? What if business insights soared from carefully crafted algorithms that fueled confident business decisions? What if the scientific discovery was made safer and faster without the fear of an imminent FDA audit? Life sciences companies are challenged because the very core of their work is about human existence – improving and extending life itself. Regulators have massive civic responsibilities, but the government regulations slow the advancement of life sciences and medicine.At USDM Life Sciences, our purpose is to bring clarity and action at the interplay of technology and regulations to help biotech, pharma, and medical device companies deliver trailblazing outcomes. We help our customers utilize cutting-edge technology to increase their speed to market while ensuring continuous compliance and patient safety. Google, Microsoft, Amazon, Oracle, and every other top technology company trust USDM to ensure their technology is adopted effectively, powerfully, and in compliance. Thousands of life science companies choose USDM to bring the future of work into the present. We make digital transformation in highly regulated areas possible, even simple, and everyone wins – especially the patient. Technology optimized. Compliance simplified.
See more USDM Life Sciences offers

Job description

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Your missions

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is seeking a Senior Director of Quality Assurance for our client.

Primary Responsibilities

  • Develop QA vision and mission and inspire team and organization to think and act in a Quality-first mindset
  • Lead the Quality organization to lead, hold accountability, and provide overall quality oversight of internal processes and procedures as well as work closely with contract manufacturing, contract laboratories, clinical research organizations, raw material, and service providers
  • Collaborate with senior leadership to provide strategic and technical guidance of Quality Assurance activities and outcomes.
  • Responsible for fulfilling managerial responsibilities in accordance with policies, procedures and state, federal and local laws
  • Lead with a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors
  • Provide strong strategic leadership for QA in support of Good Manufacturing Practices (GMPs) and Good Clinical practices (GCPs)
  • Help to implement, monitor, and promote good practice of all Quality Assurance Systems to ensure compliance with relevant FDA, EMA/other regulations/directives/requirements and ICH guidelines
  • Establish and oversee required phase-appropriate GxP systems
  • Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DS/DP release and CAPAs.
  • Develop and implement a common platform of quality and compliance systems, tools, procedures, and standards company-wide
  • Evolve, audit, and monitor Standard Operating Procedures (SOPs) to ensure they are in accordance with GxP guidelines. Carry out corrective actions for identified deviations
  • Design, develop, and review QA standards and procedures (i.e., policy documents and SOPs). Review and support deployment of Quality Standards across R&D, CMC, Clinical
  • Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s, CMOs, CROs, and Packaging Facilities
  • Ensure completeness of technical evaluation and quality due diligence activities in support of CDMO/CRO site selection process
  • Provide stewardship of the quality risk profile and team risk log, and approve risk controls strategies at CDMOs/CROs both in the selection and manage phases.
  • Review Quality Agreements, Master Service Agreement and protocols for CDMOs and
  • CROs to implement in order to ensure requirements for regulatory filing
  • Drive process and product quality through effective CMC quality systems, ensuring adequate supplier oversight/surveillance
  • Approve Protocol and Reports, Master Batch Records and Executed Batch Records at the CDMO and the CROs for Filling and Packaging
  • Ensure that all necessary steps are added to the Process Control Strategy
  • Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate
  • Ensure that all products manufactured meet the registration and cGMP requirements based on FDA /global regulatory requirements.
  • Ensure that DB and our partners are inspection-ready for health authority audits by regulatory agencies; lead engagements with health authorities
  • Accountable for training and education on GxPs and SOPs company-wide
  • Accountable for the preparation and conduct of all inspections by any regulatory authority
  • Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures. Strategize responses to regulatory questions during review period and product lifecycle.
  • Provide direct oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections
  • Ensures compliance throughout organization conforms to applicable local and global health authority requirements
  • Monitor, maintain and manage Quality Management System is compliant with guidance standard requirements
  • Ensures effective Quality function partnership with other areas of Impact including CMC, Manufacturing, R&D, Clinical, Clinical Operations, Commercial and IT
  • Ensures establishment, maintenance and effectiveness of the Quality System within R&D, Clinical Operations, and IT
  • Ensures appropriate quality systems and procedures are in place and adhered to across all functional groups
  • Ensures site is following regulations (FDA, EU, etc.) utilizing internal and external auditing and in collaboration with operational organizations and Compliance Organization
  • Leads site efforts during Regulatory (FDA, EU, etc.) inspections, ensuring issues and observations are properly addressed; interacts with Regulatory officials externally regarding issues of compliance impacting operations
  • Identifies, acquires, develops, and deploys talent across the Operational Quality unit
  • Develops and manages overall budget for Quality Operations
  • Continuous improvement with Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), EU, and other pertinent compliance organizations and regulations
  • Quality control review of receiving, packaging and shipping activities which includes approving records
  • Support Regulatory submissions and Amendments (CMC).

Qualifications

  • Accountable for training and education on GxPs and SOPs company-wide
  • Accountable for the preparation and conduct of all inspections by any regulatory authority
  • Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures. Strategize responses to regulatory questions during review period and product lifecycle.
  • Provide direct oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections
  • Assume leadership roles in CMC and Clinical Operations teams
  • Collaborate with CMC Leads, and clinical leads partners to ensure successful planning, execution and delivery of projects.
  • Ability to incorporate proper Six Sigma Principles and Tools to perform best investigation practices.
  • Ability to incorporate strategic, long- and short-range planning principles and methods.
  • Develop and implement pharmaceutical processes, principles, practices, and their applications to ensure that there are no impacts to commercial products
  • Apply project management principles and techniques.
  • Ability to hold all staff accountable to maintaining current company policies and procedures, including safety rules & regulations.
  • Partner with Computer system validation and software application validation
  • Prior experience with budget preparation and management
  • Leadership direction, training and development practices and methods.
  • Researching, interpreting, and analyzing reports, compliance requirements, regulations, contracts, and data.
  • Experience with analyzing and troubleshooting problems, identifying potential solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
  • Managing multiple projects.
  • Communicating clearly and concisely, both orally and in writing. Polished presentation skills.
  • Establishing and maintaining effective working relationships with individuals across a variety of organizations within the company. Skilled at influencing and negotiation.
  • Responding to complex inquiries from management and regulatory agencies.
  • Establishing organizational goals and objectives, developing, and implementing plans to achieve them.
  • Interpreting and applying Federal, State, and local policies, laws and regulations and other country specific and applicable laws and regulations.
  • Strong prioritization skills including the ability to make complex decisions and willingness to defend difficult positions
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
  • Demonstrated leadership ability as well as ability to be a collaborator and work well within cross-functional teams
  • Ability to motivate and lead others
  • Excellent oral communication and writing skills Change management/ change enabler embraces the challenges of a fast-changing environment
  • Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
  • Travel: Up to 25% of the time, including international travel

Education & Certifications

  • Bachelor’s Degree.

Compensation

Salary/Hourly Rate Range (W2): USD 185000 – 225000

Note: This is a direct hire position with the client.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
Check out the description to know which languages are mandatory.

Hard Skills

Presentation TrainingBudget ManagementChange ManagementGood Clinical Practices (GCP)Negotiation StrategiesRegulatory ComplianceProject Management

Soft Skills

  • Problem Solving
  • Verbal Communication Skills
  • Analytical Thinking
  • Leadership
  • Quality Assurance
  • Collaboration
Are you interested?

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