In support of the Chief Quality Officer, define and shape the Quality strategy for the Supply Chain and In-Market Quality organization. Responsible for providing leadership and direction to Quality organization in markets globally, to ensure product release and distribution are conducted pursuant to market Current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) requirements. This responsibility covers Quality directives, guidelines, and leadership to the Global Supply Chain (GSC) network, including product complaints, serialization, product surety, warehousing and transportation.

The position leads and influences a dynamic and diverse staff of Quality professionals within markets and global Quality roles, and is responsible for advancing Quality and Compliance Excellence within each market including post market management of cGMP and GDP activities within the Supply Chain network.

The following organizations report to this position; Distribution Quality, In-Market Quality teams, Clinical QP team, Product Complaints, Product Suretyand Serialization

Key Responsibilities

• Implementation of Global QMS standards across all affiliate markets
• Overall management of customer complaints including product and market trending and regulatory reporting
• Harmonizes and aligns the practices between the different markets and the Supply Chain network
• Ensures implementation of Quality Operations in local markets and supply chain Quality including Supplier Management oversight, customers oversight, providing quality input on shortage situations oversight reporting to Health Authority, and performs any market action, recall
• Assumes responsibility for market import, distribution controls, product surety, serialization, and when necessary, recall management.
• Overall responsibility for market release as required through local RP release activities
• Ensures quality and compliance is monitored by identifying and defining appropriate quality metrics, identifies gaps, and identifies and provides sustainable corrective actions and drives proactive Right First Time Culture
• Responsible for inspection readiness and compliance in each market
• Qualification strategy of Primary and Secondary transportation, in collaboration with Global Supply Chain
• Deals with complex issues across different business units and geographies using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.
• Impacts and influences the organization by escalating quality issues and decisions which impact the business and Supply Chain.
• Actively participates to company business growth and objectives for quality alignment.
• Responsible for defining the strategy, process and metrics for Global Complaint Management, Regulatory Reporting (Medical Device Reporting (US and EUMDR)), Product Security Investigations, and Complaint Trending for Global Operations
• Drives a Quality culture by anticipating and proactively responding to new directives (regulatory surveillance) and change, encouraging Quality Councils in local markets and chairing the Global Supply Chain Quality Council

Qualifications & Experience

• Bachelors degree required. Advanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) preferred.
• 15 years of experience managing Quality and Compliance organizations.
• Proficiency in Quality compliance processes and regulations, e.g., cGMP/GDP regulations, promulgated by the FDA, EMA or equivalent regulatory Agencies, and requirements for pharmaceutical products distribution
• A thorough understanding of company policies and regulatory requirements
• Thorough understanding of compliance and technical areas related to supply chain and in-market quality
• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
• Fluent English required, and bilingual preferred
• Experienced global leader managing dynamic and diverse teams of professionals located in various markets
• Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the overall business (end to end enterprise) and makes the best decisions for the Organization.
• Excellent influencing and negotiating experience and capabilities in a matrix environment.
• Must be able to interact with senior leaders in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of GQ and interface with stakeholders in a matrix environment.
• Uses judgment to make sound decisions based on information gathered and analyzed.
• Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
• Sets and maintains high performance standards. Pays close attention to detail, accuracy, and completeness.
• Adapts to changing work environments, work priorities and organizational needs.
• Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.
• Enterprise advocate: appropriately evaluates tradeoffs to make bold decisions that are in the best interest of BMS and of our patients; understanding the bigger picture beyond own functional area, seeks to have an impact on organization wide performance; embrace complexity but strive for simplicity
• External mastery: constantly looks outside the organization to understand customer needs, competitors and global trends and uses the data to achieve a competitive advantage for BMS
• Change Activator: Relentlessly identifies and creates game-changing opportunities that lead to higher organization performance and influences others to do the same
• Courageous Innovator: stretches beyond the expected to succeed in a rapidly evolving, strategic and transformational environment
• Authentic Leadership: Demonstrates an honest and unbiased understanding of their own strengths, limitations, and values; lives up to their principles and conviction without being rigid or dogmatic; generates trust by maintaining the highest level of consistency between their words and their actions.
• Talent Developer; proactively develops talent for the long and short-term, both within and outside their team.
• This role requires frequent travel to Above Market locations, and cluster markets