Head of Quality

Ironwood Pharmaceuticals, Inc.

Quality Assurance

June 11, 2014

Position Description:

The Ironwood Head of Quality (HoQ) is responsible for the development, realization and execution of cost effective, risk-based, and compliant quality assurance and compliance programs and systems in support of the company infrastructure as well as our external collaborations in order to fully support Ironwood’s drug development and commercial manufacturing activities (domestic and International.)  As a member of the Global Operations Senior Leadership Team, the HoQ will not only develop, inspire, lead and manage his/her department and activities (currently approximately 20 professionals), but also seamlessly collaborate and lead cross-functional processes and systems with Technical Operations, Manufacturing, Supply Chain and Operational Excellence, to enable overall success of stakeholders and partner organizations, alike. The HoQ forms close alliance with the internal functions to assure alignment of goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, and GLP compliance and realization of other value-added guidelines and best practices. The HoQ must be capable of formally/informally influencing, leading and guiding partner companies and external suppliers through collaborative, actionable and common goals and objectives enabling efficient, effective and compliant overall success and execution.

Responsibilities:

  • Enables the cross-functional success, growth and development of Global Operations approaches, initiatives, processes, projects and most importantly, staff and peers;
  • Provide savvy, experienced, credible business leadership through the lens of a deep Quality mindset, focused on enabling successful business and organizational outcomes;
  • Sets, enables and models a culture of collaboration and alignment among critical functions to ensure strategic objectives are met across all aspects of our operations and quality programs, processes and projects;
  • Collaborates with internal and external stakeholders and partners to enable and ensure appropriate implementation of the quality assurance requirements of Drug cGMPs, GCPs, GLPs and associated industry guidelines as appropriate;
  • With input from R&D functional leaders and Global Operations management, establishes QA strategic plans in support of R&D and commercial product quality assurance requirements for new drug candidates and ensures that those plans are implemented;
  • Leads, inspires, develops and manages a highly-capable organization of Quality professionals with a clear vision and pragmatic collaborative execution to install and realize the appropriate Quality processes, systems and relationships to drive world-class performance and development of an exceptional and admired team;
  • Develops key quality processes, metrics and indicators to measure, trend manage and improve key quality attributes of our virtual supply network, as well as strategies and tactics to communicate progress and issue resolution to appropriate internal/external stakeholders;
  • Manages and develops a group of Quality professionals who are collectively responsible for carrying out the QA mission and responsibilities, including:
    • Assurance that the appropriate suite of Standard Operating Procedures are in place and optimally maintained to support the critical drug development activities as well as our vendor relationships with our external CRO or CMOs;
    • Coordination and execution of periodic Quality Management Reviews and  trend analysis of all aspects of GXP operations;
    • Ensures the review and audit of internal department processes for compliance with applicable GCP, GMP and/or GLP regulations or guidance’s;
    • Ensures a robust and risk based audit program is successfully realized throughout our vendor network;
    • Facilitates the appropriate authoring and implementing of QA SOPs as well as review of functional SOPs;
    • Assures the planning and conduct of periodic compliance training on GLP, GMP and GCP regulations;
    • Managing and coordinating (with internal functions, partners, CROs and CMOs) the regulatory inspections for Ironwood as well as participation as appropriate in the company’s GXP regulatory inspections;
    • Acts as the company’s primary interface for communication with Regulatory agency field inspectors and ensures prompt and complete response to all regulatory inspection findings;
    • Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our CMOs, CROs, partners and suppliers. 

Qualifications and Experience: 

  • Advanced degree in a scientific or operational discipline relevant to the life sciences and / or operations areas;
  • 15+ years of quality assurance experience in a corporate drug development organization including several years experience in small molecule and/or peptide drug development;
  • Multidiscipline expertise and experience in a CMC QA role as well as familiarity with Clinical and Non-Clinical requirements and responsibilities;
  • Excellent working knowledge, understanding and experience with the practical implementation of FDA and EMA regulations and guidelines in GLP, GCP and GXP environments;
  • Highly capable and knowledgeable in the concepts, practices and leadership of process-based management and team governance;
  • Established leader in the pharmaceutical industry with clear and proven capability developing, communicating, leading, managing and inspiring within and beyond Quality organizations and efforts;
  • Exceptional oral and written communication skills to all employment levels, Board of Directors and external partners, suppliers and industry organizations;
  • Proficient in understanding and analyzing financial reports and overall business acumen;
  • Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a highly collaborative and engaged environment;
  • Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact and diplomacy. 

Personal Characteristics: 

  • A proven ability to operate effectively in a rapidly changing environment where analytical skills, technical depth, collaboration and leadership agility are equally important; a strategic thinker who is operationally focused and capable in managing diverse agendas and personalities;
  • A sought-after advisor, mentor, thinker – within and beyond the Quality arena; ability to lead and influence in a highly matrixes organization with complete transparency;
  • Self-aware, self-motivated and self-confident individual who is comfortable and capable in operating with varying levels of direction who thrives in a dynamic environment as a leader influencing chance, transformation and growth;
  • An overt simplifier who can effectively and appropriately distill and reduce complex situations, goals, tasks and/or opportunities to a workable set of fundamentals so that all team members can understand, prioritize, align and take action;
  • Brings a demonstrated ability to work with others rather than through others;
  • Maintains poise under pressure and readily demonstrates and optimistic nature;
  • A highly capable problem solver and hurdle-eradicator who is consistently invited in (and re-invited) to solve complex, cross-functional and meaningful challenges in a recognized value-added way;
  • Able to engender trust and respect quickly as a manager of people, with a priority for the professional development and growth of staff and teammates, focused on building capability at both the organizational and individual level;
  • Enjoyable to work with, learn from and teach with, while overcoming challenges and creating opportunities;
  • Long-term thinker and proactive leader – capable of understanding and translating the big picture to actionable and understood plans and activities;
  • Data-driven realist focused on doing the right thing for the company optimally capable of balancing need, risk and impact with urgency.

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