Quality Risk Specialist III

POSITION SUMMARY

The Quality Risk and Compliance Mission is to provide best practices of quality risk management data integrity and auditing to ensure patient safety and product quality at PTx. The Quality Risk Specialist III serves to keep patients safe by managing risks to cGMP manufacturing (drug product and drug substance) and testing operations. This position is primarily responsible for supporting growth of the Data Integrity and Quality Risk Management programs.

PRIMARY RESPONSIBILITIES

• Support the development and continuous improvement of the Quality Risk Management program to ensure product quality patient safety and regulatory compliance.
• Facilitate Quality Risk Assessments using established methodologies including Failure Mode and Effects Analysis (FMEA) and risk-based assessments.
• Partner with cross-functional subject matter experts to identify evaluate and mitigate quality risks to acceptable levels including data integrity risks.
• Maintain the risk library through periodic reviews change control assessments and updates to existing risk evaluations.
• Evaluate residual risks following implementation of mitigation measures to ensure effectiveness.
• Serve as a Quality Risk Management subject matter expert providing guidance coaching and training to risk facilitators process owners and cross-functional teams.
• Develop training materials and deliver training on risk management principles methodologies and tools.
• Prepare risk assessment reports and manage documentation review and approval workflows through MasterControl.
• Communicate significant quality risks trends and mitigation strategies to leadership through Management Review Quality Council and risk reporting processes.
• Collaborate with stakeholders to resolve complex risk-related issues escalate concerns and implement sustainable process improvements.
• Manage multiple risk assessment projects independently ensuring timely completion and alignment with organizational priorities.
• Maintain knowledge of applicable GMP regulations ICH Q9 guidelines industry best practices and evolving quality risk management standards.
• Ensure compliance with company SOPs applicable regulatory requirements and mandatory Quality and Compliance training.

KNOWLEDGE SKILLS ABILITIES

Required:

• Well-grounded in FDA and/or other regulatory agencies expectations.
• Experienced in report writing for this regulated industry.
• Experienced in Quality Risk Management principles and applications.
• Experience participating in external agency inspections ( EMA)
• Strong critical thinking analytical and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
• Resourceful with proven ability to lead manage and leverage an extensive internal network of stakeholders team members and external resources to plan and resolve issues. Strong collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• Excellent soft skills including a bias towards action the ability and willingness to give and receive constructive feedback is comfortable working within a diverse team and across multiple functions exhibits a consistently constructive attitude and is adaptable and at ease with handling unexpected changes and challenges.
• Solid English language communication skills both oral and written are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask actively participating in cross-functional meetings.
• Proficiency with MS Office products especially Word and Excel essential; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Demonstrated experience in writing risk assessment reports with clear justification/rationale that informs the risk scores and draws logical clearly written conclusions based on risk.
• Demonstrated experience in leading risk teams in performing risk analysis with various risk tools including assessing risks to data integrity.
• Experience creating training materials and delivering training in person virtual or through web videos.
• Experience with Stature software for conducting risk analysis.
• Knowledge of Data Integrity in a highly regulated environment.
• Software application experience with Smartsheet MS Project and SharePoint.
• Project management experience or formal training.

EXPERIENCE & EDUCATION

Required:

• High School diploma or GED.
• 4 years of experience in manufacturing testing quality or regulated operational environment
• 3 years of conducting or supporting formal risk assessments in a regulated setting.

Preferred:

• Bachelors Degree in Science Computers or Quality Engineering
• ASQ credential specialty in Risk Management and Data Quality
• ASQ certifications such as Quality Management (CMQ/OE) or Quality Engineer (CQE) Lean Six Sigma Greenbelt or Blackbelt (CCSGB or CCSBB) or related certification

Please note that we are unable to offer sponsorship for open positions at this time.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for the Quality Risk Specialist IV is $90000 $115000. Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical dental vision FSA/DCA HRA disability and life insurance coverage all full-time regular Partners enjoy a casual Hybrid or Remote workplace program for many roles. We also offer a highly competitive compensation and benefits package including an annual discretionary cash bonus and a 401(k) matching program. Partners in the Seattle area can take advantage of a free ORCA pass and we also provide tuition and continuing education assistance to support ongoing professional development. Recognition for outstanding contributions and achievements is a core part of our culture.

Partner Therapeuticsis an Equal Opportunity Employer and does not discriminate on the basis of race color religion sex age national origin veteran status marital status sexual orientation gender identity disability or any other category prohibited by local state or federal law. This policy applies to all aspects of employment including recruitment placement promotion transfer demotion compensation benefits social and recreationalactivitiesand termination.

Required Experience:

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