Quality Risk Specialist IV (Hybrid)

POSITION SUMMARY

The Quality Risk & Compliance function establishes and maintains best practices for Quality Risk Management Data Integrity and Audit Readiness to support patient safety product quality and cGMP compliance at PTx. The Quality Risk & Compliance Specialist is responsible for identifying assessing documenting and monitoring quality risks associated with cGMP manufacturing testing and supporting GxP operations.

PRIMARY RESPONSIBILITIES

• Serves as a subject matter expert (SME) for Quality Risk Management and Data Integrity programs providing guidance to cross-functional teams and site stakeholders.
• Facilitates cross-functional teams in the application of Quality Risk Management and Data Integrity principles across GxP manufacturing testing and support operations.
• Supports GxP change controls by:
  • Participating in pre-change planning meetings
  • Representing Quality Risk at Change Review Board meetings
  • Assessing the impact of proposed changes on existing risk assessments and the living risk library
  • Determining when a change requires a formal risk assessment
  • Ensuring applicable risk assessments are updated routed and approved in alignment with internal procedures.
• Leads formal risk assessments using recognized risk tools including process FMEA design FMEA and other appropriate Quality Risk Management methodologies.
• Guides subject matter experts in identifying appropriate risk controls mitigation strategies and preventive actions.
• Authors reviews and routes Risk Assessment Reports in MasterControl ensuring conclusions rationales mitigations and residual risk determinations are clearly documented.
• Evaluates residual risk following implementation of mitigation activities and determine whether risks have been reduced to an acceptable level.
• Maintains the living risk library through periodic review annual updates and incorporation of new or revised risk information.
• Coaches SMEs and cross-functional Partners on effective mitigation strategies risk ranking and risk-based decision-making.
• Develops and delivers training on Quality Risk Management tools and methodologies including process and design FMEAs.
• Manages multiple risk-related projects independently ensuring strong organization prioritization follow-through and timely completion.
• Monitors and interprets FDA EMA ICH and other regulatory expectations related to Quality Risk Management Data Integrity and impurity risk controls including but not limited to:
  • ICH Q9(R1) Quality Risk Management
  • ICH Q3D(R2) Elemental Impurities
  • ICH Q3E Assessment and Control of Extractables and Leachables
  • FDA Guidance: Control of Nitrosamine Impurities in Human Drugs
  • FDA Guidance: Data Integrity and Compliance with Drug cGMP
• Presents Quality Risk Management program metrics trends and key risks during Quality Management Review.
• Manages significant risks and mitigation activities through the Quality Risk Register and the Quality Risk Council or other appropriate governance forums.
• Administers Advanced Risk Assessment software used to document analyze and maintain risk assessments.
• Drives issue resolution escalate concerns appropriately and implement preventive improvements that strengthen the Quality Risk Management program.
• Applies industry best practices through continuous learning benchmarking and external networking.
• Participates in cross-functional projects that support business needs compliance improvement and professional development.
• Complies with all internal SOPs cGMP requirements safety procedures and applicable regulatory standards.
• Completes all required Quality and Compliance training within assigned timelines.

KNOWLEDGE SKILLS ABILITIES

Required:

• Strong working knowledge of Quality Risk Management principles tools and application in a regulated GxP environment.
• Hands-on experience facilitating formal risk assessments with cross-functional teams.
• Experience applying risk tools such as FMEA risk ranking and filtering hazard analysis or other structured risk assessment methodologies.
• Ability to translate complex technical manufacturing testing and quality information into clear risk assessments reports conclusions and mitigation plans.
• Strong risk assessment writing skills including clear documentation of assumptions rationale conclusions mitigations and/or residual risk when writing risk assessment reports quality procedures and supporting documentation for a regulated industry.
• Solid understanding of FDA EMA ICH USP and cGMP expectations related to Quality Risk Management Data Integrity and pharmaceutical quality systems.
• Experience supporting or interacting with regulatory inspections audits or inspection-readiness activities.
• 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 questions. Comfortable 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:

• Experience leading cross-functional risk teams using multiple Quality Risk Management tools.
• Experience developing and delivering training in person or virtually.
• Experience with Advanced Risk Assessment software or other risk management platforms.
• Familiarity with MasterControl SharePoint and Smartsheet software.
• Project management training certification or practical project leadership experience.
• Knowledge of Data Integrity expectations and practical controls within GxP systems and processes.

EXPERIENCE & EDUCATION

Required:

• High school diploma or GED
• 6 years of experience in a GxP manufacturing testing quality or regulated operational environment
• Experience conducting or supporting formal risk assessments in a regulated setting

Preferred:

• Bachelors degree in Science Computer Science or Quality Engineering
• 8 years of progressively responsible GxP experience
• Experience supporting biopharmaceutical large-molecule products
• ASQ credential specialty in Risk Management and Data Quality
• ASQ certifications such as Quality Management (CMQ/OE) or Quality Engineer (CQE) or related certification

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for the Quality Control Associate III is $110000 $137000. 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.