Compliance Lead
AstraZeneca

Job Info

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Do you have experience in regulatory and/or internal audits and inspection and a passion for serving patients? Would you like to apply your expertise by joining Inhalation Product Development? Then our Compliance Lead position might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.

Inhalation Product Development (IPD) sits within Pharmaceutical Technology and Development (PT&D) to ensure the successful development, launch and commercialization of our portfolio of inhaled drug/device products It plays a key role in the company's and PT&D's strategy to accelerate more new products to patients.

As the compliance leader within IPD, your key responsibility will be to ensure that all activities and facilities are in a state of compliance with cGMP and GLS (General Laboratory Standards) with audit readiness. You will work to align global standards, ensure appropriate training and systems availability across the global IPD and PT&D for the development of inhaled products. Based in Durham, NC, you will be an individual contributor and report directly to the Vice President, Head of Inhalation Product Development.

This role requires an experienced and motivated leader within pharmaceutical development who has a track record of maintaining functional compliance to cGMP and GLS standards. To be successful in this role this leader must understand and apply LEAN principles and problem solving, is experienced working in a complex multi-national environment and can demonstrate global thinking and cultural awareness.

What you will do:

• Builds, support delivery of and ensure compliance with required laboratory training programs across GMP and non-GMP laboratories and manufacturing areas within IPD.
  
• Coordinate and assist in developing business processes related to laboratory and manufacturing operations in IPD
  
• Subject matter expert and support for quality event reporting and closure including deviations, CAPA, annual document updates, compliance IT systems etc.
  
• Key member and/or leader of IPD and PT&D quality networks
  
• Lead functional self-inspection and readiness activities for all areas of IPD
  
• Conduct site functional self-inspections (May travel nationally/internationally and represent company during audits)
  
• Lead development and optimization of quality metrics to present to management periodically
  
• Lead the generation and alignment of responses to internal quality audit observations in the GMP and non-GMP areas
  
• Assist in planning and coordinating Corporate, Customer and Regulatory Agency audits/inspections
  
• Lead and support delivery of continuous improvement activities in key strategic areas of lab and manufacturing area operations.
  

Minimum Qualifications:

• BS University degree in a relevant scientific field is required and a master's degree is preferred
  
• Extensive experience working in a regulated pharmaceutical laboratory environment
  
• Leadership experience promoting, motivating and empowering diverse and inclusive culture to support accomplishment of individual, team and organizational objectives in international teams
  
• Strong Networking skills across complex, multi-national organization
  
• Ability to effectively lead in a matrix organization where execution depends on a team that does not directly report to you.
  
• Basic understanding and application of GxP principals, concepts, practices and standards
  
• General knowledge of regulatory requirements (eg. 21 CFR Parts 210, 211, 820; EU Volume 4; PIC/S; ICH; ISO; Pharmacopoeia)
  
• Proven experience with regulatory and/or internal audits and inspections
  
• Understanding and use of LEAN and/or Operational Excellence (FMEA, DMAIC, root cause analysis etc.) concepts
  
• Experience authoring and following standard operating procedures (SOPs)
  
• Able to apply and lead risk management philosophy
  
• Ability to transfer knowledge: developing training materials and conveying sophisticated concepts
  
• Strong interpersonal skills and the flexibility to prioritize multiple tasks and deadlines
  

Preferred Qualifications:

• PhD in scientific field
  
• Clear understanding of the pharmaceutical development processes and considerations with experience in technical development roles.
  
• Ability to lead cross functional working groups and teams
  
• Excellent knowledge of AstraZeneca policies, procedures and guidelines
  

Why AstraZeneca

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

So, what's next

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!

Find out more on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/
  
• Facebook https://www.facebook.com/astrazenecacareers/
  
• Instagram https://www.instagram.com/astrazeneca/?hl=en
  
• About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
  

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.

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