• Company information: *leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.

Currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. The scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies. As the first company to fully harness the power of RNA technology for human therapeutics, the platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. They are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

• Summary*: Seeking an experienced Senior Manager/Assistant Director in Quality Assurance with strong knowledge and expertise in Combination Drug Product to provide QA oversight for all stages of the Design Control process according to FDA 21 CFR Part 820.30, ISO 13485, and the quality system requirements.
• Requirements: *
• 10 years of experience in Drug Product Manufacturing
• Must have sterile fill/finish hands on experience
• Needs to have experience interacting with the fill/finish manufacturing team
• Core competencies/Responsibilities:*
• Interface with internal stakeholders and contract manufacturers to address and resolve complex technical drug-device combination product, process, and quality issues. Acts as an escalation contact for complex and high impact quality issues, concerns, and decisions.
• Support strategic relationships with internal cross-functional teams as well as related CMOs.
• Support implementation of risk management strategies.
• Provide guidance and impact assessments for Change Control, including DHF assessments.
• Ensures that performance and quality of combination products conform to established standards and regulatory agency requirements.
• Reviews regulatory documents and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance. Participates in regulatory authority inspections.
• Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA)
• Interface with contract manufacturers to address and resolve drug-device related product/process performance issues.
• Collaborate with Pharmaceutical Development team members during new combination product development and provide input into the design controls process.
• Participate in annual product reviews and assess changes and product complaints against the DHF.
• Qualification requirements:*
• B.S. in Chemistry, Chemical Engineering, or related disciplines; advance degree preferred.
• 5 – 7 years in the life sciences industry with Quality Assurance experience and 4+ years with drug product experience in a highly regulated manufacturing environment.
• QA experience in both clinical and commercial combination products.
• Demonstrates strong knowledge of medical devices, combination products (such as autoinjectors, co-packed kits, pre-filled syringes) and general pharmaceutical manufacturing.
• Strong project management and process improvement skills.
• Demonstrates understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is preferred.
• Knowledge of Risk Management principles according to ISO 14971, including the use of risk management tools such as FMEA.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Is comfortable interacting with regulatory agencies as needed.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.