What are the responsibilities and job description for the Associate Director, Functional Quality Business Partner, R&D Quality position at TekWissen ®?
Overview
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Associate Director, Functional Quality Business Partner, R&D Quality
Location: Foster City, CA 94404
Duration: 12 Months
Job Type: Contract
Work Type: Hybrid
Job Description
POSITION OVERVIEW:
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Associate Director, Functional Quality Business Partner, R&D Quality
Location: Foster City, CA 94404
Duration: 12 Months
Job Type: Contract
Work Type: Hybrid
Job Description
POSITION OVERVIEW:
- You will act as the R&D Quality Business Partner to assigned groups, such as client R&D functions or vendors supporting client R&D.
- You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Clinical Practices (GCP).
- You will educate assigned groups on client quality policy and procedural standards, GCP regulations and other requirements.
- You will provide expert advice on GCP risk minimization and mitigation.
- You will help the business understand potential impacts of risk and alternatives to best address risk.
- You will also provide leadership support in escalating quality risks or issues.
- You will participate in Quality forums, cross-functional teams and/or projects.
- You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups.
- You will collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support.
- You may support client during regulatory inspections.
- Serves as Quality Business Partner lead for assigned client R&D functions, programs and/or vendors.
- Handles multiple projects simultaneously and ensures overall and timely completion of tasks.
- Works closely with business to provide expert quality information, manage identified issues, and support continuous improvement.
- Acts as Subject Matter Expert supporting GCP cross portfolio risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.
- Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality as required on internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.
- Assists in readiness preparation, and/or directly supports regulatory agency inspection.
- Supports deviation identification, reporting, and CAPA development.
- Supports evaluation of new regulations and potential implications for client R&D and/or R&D vendors.
- Evaluates, writes and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS.
- Collaborates with other R&D Quality teams to ensure assigned functions, programs or vendors have timely and robust support for quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation, and other related activities.
- May lead or support projects.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- Education & Experience
- PharmD/PhD with 2 years’ experience.
- MA/MS/MBA with 8 years’ relevant experience.
- BA/BS with 10 years’ relevant experience.
- Significant experience advising business functions in the biopharma industry on GCP quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement.
- Previous GCP quality experience at a Sponsor or CRO; Previous experience as an auditor highly desired.
- Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.
- Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials, or other drug development activities.
- Experience working with total quality management methodologies, such as Lean Six Sigma, is a plus.
- Thorough knowledge of standards, systems, policies and procedures that enable Good Clinical Practices (GCP), QMS operations and compliance within the biopharma industry. Experience with Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP) and Electronic Systems Compliance (ESC) is a plus.
- Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
- Demonstrates advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex systems and data and understanding the quality and compliance implications.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills.
- Strong negotiation and conflict resolution skills.
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.
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