Portfolio Quality Lead (Director)
San Diego , California
December 17, 2016

About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The Clinical Quality Lead (CQL) is responsible for driving Level One quality for assets within specific categories by maintaining 'quality' line-of-sight for assets/protocols. With this focus, the CQL role brings deep knowledge of Level One quality issues within assets and across clinical trial business process areas. In partnership with the appropriate roles in Clinical Science and Operations, the CQL will ensure asset and study level quality oversight, manage relevant asset and study level quality issues, and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. Point person to stakeholders and asset teams for asset and study quality risk management, quality issues management and general GCP guidance.

As CQLs are assigned to specific asset(s) within a category, responsibility includes:

Level 1 GCP Quality :
• Provide single point of accountability to clinical teams for GCP advice and guidance

• Strategically utilize quality and compliance data to monitor portfolio quality to understand and recognize potential risks and ongoing issues. Ensure project teams are aware of risks, issues and general quality state of asset/study. Analyze and interpret data from the following sources to drive change:

- Quality Standards Metrics
- COL Oversight Visit and Site Health data
- Significant Quality Events (SQE)
- Audit/Inspection Metrics and Trends
- Protocol Deviations Metrics and Trends
- Integrated Quality Management Plan (IQMP)

• Partner with QPRM (Quality Performance and Risk Management) on the development of metrics

• Provide Level 1 portfolio quality expertise on SQE investigation teams

• Evaluate effectiveness of site audit remediation measures and drive learnings across the asset and/or portfolio

• For persistently red metrics, guide project teams through a CAPA discussion identifying appropriate actions/remediations

IQMP Development and Oversight (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS)

• Oversee study-level quality risk management activities (including IQMP activity)

• Drive consistent implementation of IQMP across study teams

• Facilitate IQMP development to ensure that study teams:

- Identify factors that are critical to quality and pre-specify appropriate quality metrics, and
- Identify high priority risks to quality and prospectively implement appropriate mitigation plans

• Activate IQMP, via participation on the asset clinical operations team, by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner.

• Evaluate the quality of approved IQMPs through IQMP effectiveness reviews and/or IQMP QC reviews

• Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CQL team

• Provide feedback to IQMP BPO to continuously improve IQMP approach

Escalation, Communication, and Governance
• Develop and present quality point of view at governance meetings

• Guide asset/study team on appropriate escalation pathways for quality concerns

• Escalate/communicate quality issues to:

- Governance committees (e.g. CDQ Quality Review, OpCo, QOC, QCC)
- IPLT for process level issues
- Vendor Quality Management

• Advocate for study teams' continuous improvement feedback on business processes to BPOs

• Communicate key quality information (e.g. inspection/audit learnings) across asset/study teams and serve as asset quality expert

Inspection Readiness and Preparation
• Provide Study Team Inspection Readiness (IR) guidance and support; lead teams through pre-submission IR deep-dive in partnership with Audit and Inspection Quality

• Participate and guide team with inspection preparation, conduct and response activities

• Support team during inspection

A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:
• BS - 10 years or equivalent
• MS/MBA - 5 years or equivalent
• Ph.D./MD - 5 years or equivalent
• Ability to build strong network/knowledge/relationships with internal/external stakeholders
• Advanced knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Familiarity with the assigned portfolio and the company assets, relevant key therapeutic areas

Prior Experience:
• Advanced clinical trials experience, especially operational processes and/or systems.
• Advanced Quality Management experience including use of metrics to drive quality and compliance
• Excellent understanding of the company processes and SOPs
• Skilled in project management
• Demonstrated experience engaging leaders and establishing stakeholders relationships
• Strong influencing skills with ability to influence a broad range of global stakeholders.
• Strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization
• Experience of drug development across one or more business lines
• Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries
• Ability to work successfully with internal and external partners
• Excellent communication skills adaptable to meet the needs of diverse stakeholder groups
• Experience of conducting, managing or participating in an audit and/or inspection process
• Record of achievement and delivery for personal and team goals
• Ability to balance and prioritize a diverse and demanding workload
• Works independently and proactively set own work agenda with minimum guidance

Technical Competencies:
• Strong knowledge in quality areas (i.e. audit, inspection, compliance, and inspection readiness fields)
• Advanced knowledge in clinical trial development
• Use of Metrics to drive quality and compliance, including ability to use metrics and related data to determine where quality issues may exist and address appropriately
• Quality related experience including working knowledge in areas of:
• Quality and compliance management, QC
• Root Cause Analysis
• Metrics development and utilization
• Audit and Inspection conduct and CAPA response process
• ICH GCP, and Regulatory obligations
• Inspection Readiness
• Project/initiative coordination and management skills
• Knowledge of the company clinical trial and quality management processes
• Project Management skills/experience
• Spotfire and Excel skills/experience
• Ability to provide guidance and instruction in Inspection Readiness and consultation for audit responses
• Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines
• Knowledge of the company SOPs and processes
• Ability to implement strategies using coordinated and transparent metrics to track and manage compliance
• Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement

Sitting, Standing, Walking, Carrying up to 20 pounds, perform complex calculations and data analyses

Mostly office based, with occasional travel.

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.

A little about us:
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