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This is what you will do:

  • As the Associate Director of US Commercial Quality and Strategic Quality Management, you will lead the local US Commercial QA efforts, ensuring that the Alexion GMP/GDP QMS and relevant US regulatory requirements are met by the entire US Commercial teams.
  • You will play a crucial role as a key member of the Country/Affiliate Strategic Quality Management (SQM) Team, actively promoting a Quality Culture in collaboration with international Country/Affiliate Regulatory and Quality Assurance (CRQA). This involves fostering a quality mindset, facilitating learning, and driving sustainable continuous improvement.
  • Contribute to defining, monitoring, and continuously improving CRQA KPIs/metrics to enhance overall quality performance.
  • Collaborate with CRQA, Quality business partners (QBRs), and other colleagues to support key process/system improvements.
  • As a valuable member of the SQM team, participate in enhancing CRQA's Annual Quality Plan, CRQA Quality Management Review, Audit & Inspection readiness (AIR), Active Risk Management, and other quality governance mechanisms, ensuring continuous improvement.

You will be responsible for:

As the US Commercial QA Lead (~30%)

  • Providing leadership in ensuring compliance within US Commercial functions to Alexion's Global Quality and Compliance systems, associated procedures, and standards.
  • Collaborate with operational groups locally, regionally, and globally to promote a proactive approach to quality and compliance, implementing Alexion Policies, Quality Standard Operating Procedures (SOPs), and relevant US GxP guidelines.
  • Establish and maintain a quality performance-driven operations model for US Commercial teams, focusing on risk management, strategic program implementation, operational performance, and efficient systems and processes.
  • Foster a Culture of Quality across functional areas, ensuring consistency and standardization in quality across Commercial teams through KPI creation, oversight, and proactive risk mitigation.
  • Lead and enable process and system improvement efforts to maximize efficiency in delivering quality outcomes across US Commercial, actively engaging with business leaders to integrate quality into long-term planning and supporting expansion and new product introductions.

As as member of the SQM Team supporting all international CRQA teams (~70%):

  • Serve as a key thought leader with a creative approach to resolving complex issues, aligning program/project efforts with the short- and long-term strategic objectives of the Business Units.
  • Take the lead in establishing an Quality Culture within CRQA, promoting best practices and building a network for continuous improvement. Collaborate with senior Quality stakeholders to ensure consistent and efficient deployment of Project Management and Operational Excellence knowledge, tools, and standards
  • Support the CRQA Leadership Team in identifying, evaluating, and addressing fundamental quality risks and issues through the creation of an annual strategic quality plan. Periodically assess and escalate top risks within CRQA QMS, developing implementation plans, conducting risk assessments, and implementing contingency plans.
  • Collaborate with cross-functional stakeholders to drive improvements in current CRQA processes and infrastructure. Enhance efficiency, scalability, and robustness to support CRQA QMS performance globally. Eliminate redundancies, improve knowledge management, and integrate systems for increased productivity, transparency, and quality.
  • Assist the CRQA Leadership Team and Central Quality team in running and enhancing the Quality Management Review for Country Quality (CQ) and Division CRQA Quality Management Review. Focus on increasing management awareness and oversight of QMS performance, including inspection and audit performance, quality systems, key CQ processes, quality risks, and updates to the Annual Quality Plan focus areas.
  • Develop or review relevant GxP SOPs governing Regulatory and Quality activities, identifying areas for improvement and addressing gaps. Ensure appropriate escalations and notifications to executive-level management for all CQ issues. Collaborate with CQ colleagues and Central Quality to identify and implement innovative GxP training needs, fostering a Quality Culture in Countries/Affiliates. Facilitate Change Control Review Boards (CCRBs) and Deviation Review Boards (DRBs)
  • Foster an environment of talent development and learning to support a scalable and flexible organization that is future-focused.
  • Mentor other members of the Quality team.

You will need to have:

  • 6+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry. Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
  • Lean / Six Sigma Green Certification.
  • Extensive knowledge in a broad range of pharmaceutical regulatory activities and Quality Systems.
  • Strong Management & leadership ability
  • Self-motivated, flexible, and creative leader, able to prioritize, multitask and work in a fast-paced and demanding environment
  • Proven track record of stakeholder management
  • Ability to motivate others around a shared goal and create a compelling vision and purpose for others to strive towards
  • Exceptional communication and interpersonal skills
  • Ability to work globally in a matrix environment
  • Ability to influence senior management, peers, and other colleagues without direct reporting lines
  • Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
  • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
  • Ability to freely travel up to 20%, (domestic and international)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 

We would prefer for you to have:

  • Bachelor’s degree in life science required. Advanced degree strongly preferred.
  • A track record in driving for continuous improvement in a matrixed organization with multiple stakeholders.
  • Hands-on experience applying Project Management best practice and advanced planning and control methods to drive change in large organizations.
  • Highly developed facilitation and negotiation skills, as well as the ability to resolve conflicts and develop win-win relationships with others within the business.
  • Advanced knowledge working with analytical tool (including Powerbi and Minitab)

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Date Posted

26-Feb-2024

Closing Date

23-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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