Quality Risk Management - Senior Specialist

As part of the Quality Operations and Excellence function, the Quality Risk Management department is responsible for ensuring the Quality Risk Management (QRM) program serves patients by enabling risk-based, compliant, cGMP operational performance. This is accomplished through management of the following key areas of the QRM program:

Identifying and managing quality risks via the Risk Council and the Risk Profile Report process.

Completing and maintaining formal risk assessments (FMEA and HACCP) for the living risk library that documents risks associated with producing and testing product.

Educating, coaching and mentoring process owners, quality functions and other functional areas, in conducting less formal risk assessments (Risk Estimation Matrix, Risk Based Impact Assessments, and Comparison Matrix) in support of change controls, deviations and/or other events that trigger ad hoc risk assessments, including custom risk assessments.

Qualifying, mentoring and supporting a cross-functional group of risk facilitators that provide support to the QRM function (e.g. lead formal risk assessments, etc.)

POSITION OVERVIEW/KEY RESPONSIBILITIES:

This position is primarily responsible for continued maintenance and improvement of the QRM program by assisting in embedding quality risk management into production, testing and quality system processes.

This role currently has no direct reports to manage, but must embody considerable leadership skills to be successful (including effective intrapersonal and cross-functional communications both written and verbal, relationship building, agility and adaptability). The role holder must mentor and inspire site personnel to achieve the company’s objectives related to human resources policies, programs, and practices.

ASSIST IN MAINTENANCE AND CONTINUED IMPROVEMENT OF A PROACTIVE QRM PROGRAM BY:

Acting as a risk subject matter expert and resource to all employees in all aspects of the QRM life-cycle and program

Guiding risk teams in initiation of a risk assessment process (e.g. selecting the appropriate risk tool, completing risk assessment initiation documentation, etc.)

Guiding risk facilitators and/or risk teams in completing risk assessments (both formal and less formal tools) per QRM strategy, including facilitating risk mitigation strategies, as appropriate

Assisting risk teams with Risk Assessment report writing

Assisting risk teams with Residual Evaluation of risks after completion of risk mitigations

Tracking progress-to-plan for implementation of risk mitigations that result from risk assessments (i.e. CAPA number, due date, tasks, and owners, etc.)

Participating in Change Controls to ensure high quality risk assessments are completed using change control risk tools and to assess the impact of changes on approved Living Risk Assessment Library. Includes documenting impact results and revising risk assessments that need revisions, as appropriate

Assisting with Risk Communication (e.g. preparing Risk Profile Report, preparing power point for QRM reporting, and/or hosting all employee risk lunch and learn session, etc.)

Supporting Risk document and Training document revisions, including curriculum assignment into employee learning plans

Willing to become qualified to teach less formal risk tools (RBIA, CM and REM)

Assist with implementation and use of new risk management software application(s), includes vendor relations, contracts/agreements, software updates, user training, etc.

Assist in regulatory inspections regarding QRM

Participate cross-functionally with internal stakeholders to review, assess and establish best practices as it relates to Regulatory Intelligence & Risk on a routine basis.

Ensure processes and procedures are updated to reflect industry changes and regulatory expectations and escalate issues that are at risk.

LEADING PEOPLE:

Motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers

BASIC QUALIFICATIONS:

Bachelor’s Degree

8+ years of experience in drug manufacturing production and testing

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

Proficiency in Microsoft PowerPoint, Word, Excel, Visio, and databases or other Risk analysis software

Strong written and verbal communication skills and ability to build relationships both internal and external to the site.

PREFERRED QUALIFICATIONS:

Bachelor’s Degree in Science, Business, or Education

Previous work experience in biopharmaceutical products

Demonstrated experience in leading risk teams in performing FMEAs, HACCPs, and less formal risk analysis tools.

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 management.

Experience with Stature software for conducting risk analysis

Compensation and benefits are very competitive. They include a base salary, performance bonus, stock options and profit sharing. Our benefits include health, vision, dental and life Ins, 401(k) with match & PTO