Sr. Associate III, Quality Assurance (Quality Engineering)

Posted Yesterday
Be an Early Applicant
Triangle Trailer Park, Township of Jacksonville, NC
Senior level
Biotech
The Role
The Sr. Associate III, Quality Assurance is responsible for ensuring compliance with GMP and quality systems, overseeing quality activities, supporting capital projects, and participating in inspections. This role involves reviewing and approving GMP documentation, identifying gaps in quality systems, and providing guidance across departments.
Summary Generated by Built In

Job Description

The schedule for this position is M-F Business hours (full time, on-site)

About This Role

The Sr. Associate III of Quality Engineering is responsible for understanding quality systems and maintaining oversight of GMP activities while supporting Automation, Engineering, Facilities, Manufacturing, and Quality Assurance/Quality Control stakeholders at the Biogen Research Triangle Park (RTP) Pharma facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement cross functionally and globally. Additionally, the Sr. Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. 

What You’ll Do  

  • Assist in the development and implementation of Global Quality Systems, leading site and global initiatives, provide oversight with respect to the proper administration and adherence to all Biogen policies and procedures as well as regulatory licenses and regulations, and interfacing with key Engineering, Manufacturing, and Quality customers
  • Review of GMP raw data for compliance, review and approval of GMP documentation (including CAPAs, change controls, drawings, exceptions, procedures, records, shutdown documentation, validation protocols, work orders, etc.), and identify gaps in existing quality systems and propose solutions to site management
  • Support oversight of quality systems and GMP activities, as well as site performance monitoring systems – such as Quality Council, Site Management Review, Site Governance Boards (e.g., CAPA Review Board, Change Control Review Board, Deviation Review Board) 
  • Proactive identification and resolution of both technical and compliance issues/gaps. Develop and implement aspects of various Quality Systems/System Improvements
  • Support site capital projects by providing GMP guidance, risk management input, and quality oversight during shutdown planning, release, and other major equipment/facility improvements 
  • May support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. In addition, support the manager for activities related to training of employees, as well as compliance with training policies
  • Additional duties as assigned

Qualifications

Required Skills  

  • Bachelor’s Degree in engineering or related life sciences field
  • Minimum 7-10 years of experience working in Quality in a biotech/pharmaceutical GMP environment
  • Expertise with Change Control, Exceptions Management, and Record Issuance
  • Thorough knowledge of current global Regulatory Quality requirements
  • Knowledge of industry practices in Engineering, Quality Control, Quality Systems, and Validation 
  • Regulatory Agency inspection experience
  • Robust knowledge of labeling/packaging operations and validation 

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.


The Company
HQ: Cambridge, MA
9,575 Employees
On-site Workplace

What We Do

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.

Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.

With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

Similar Jobs

PwC Logo PwC

Managed Services - Salesforce Test Lead - Senior Associate

Artificial Intelligence • Professional Services • Business Intelligence • Consulting • Cybersecurity • Generative AI
Hybrid
45 Locations
364000 Employees
58K-161K Annually
3 Locations
97838 Employees
87K-173K Annually

Solenis Logo Solenis

Lead Quality Assurance Technologist

Industrial • Manufacturing
Greensboro, NC, USA
5522 Employees
4 Locations
1325 Employees
62K-99K Annually

Similar Companies Hiring

Pfizer Thumbnail
Pharmaceutical • Natural Language Processing • Machine Learning • Healthtech • Biotech • Artificial Intelligence
New York, NY
121990 Employees
Takeda Thumbnail
Software • Pharmaceutical • Manufacturing • Healthtech • Biotech • Analytics
Cambridge, MA
50000 Employees
Asimov Thumbnail
Machine Learning • Design • Biotech • Artificial Intelligence
Boston, MA
95 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account