Biogen · 1 hour ago
Director of Quality Control, Pharma
Triangle, NC
Full-time
Onsite
Director/Executive
$167K/yr - $230K/yr
12+ years expBiogen is a mid-sized biotechnology company committed to delivering life-changing medicines. The Director of Quality Control will provide strategic and operational leadership for the Pharma Site Quality Control Operations, ensuring the highest standards of quality through various analyses and managing QC budget plans.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Lead the Pharma Site QC Operations organization – Management of effective and efficient cGMP compliant QC laboratory operations and effective partnership within Global Quality. Plan, implement and direct activities of QC Operations Lab supervisors and managers in core functions that include all types of sampling and testing activities; provide technical support as well as facilitation of major investigations; all in support of business and manufacturing schedules
Be accountable for QC personnel staffing, their training, development, and performance consistent with requirements of GMP compliant Quality Control operation. Ensure adherence to safety regulations and requirements
As an extended member of the RTP Pharma Site Leadership team, contribute to organizational focus and strategic planning
Establish and maintain fully effective laboratory systems to ensure integrity of all laboratory results. Ensure tracking and trending are completed and evaluated for QC functions. Responsible for audits and site management review. Ensure tasks are completed to meet business initiatives within a suitable timeframe
Collaborate with various teams including Manufacturing, MFG Sciences, Technical Development, Quality Assurance, Regulatory, and Global Quality to facilitate cross-functional success
Develop and manage QC budget plans, ensuring financial discipline and alignment with company near and long-term growth strategies
Manage key site and global milestone projects, maintaining adherence to all regulatory licenses and regulations
Provide technical support, facilitate major investigations, and ensure QC laboratory operations support business and manufacturing schedules
Drive compliance and quality by supporting analytical method and process validation, instrument qualifications, and adherence to safety regulations
Qualification
Required
Bachelor's degree (B.S.) in Microbiology, Chemistry, Biochemistry, Biological Sciences, or a related field
A minimum of 12 years of relevant experience, including direct people leadership of 6+ headcount, with a history of advancement and exposure at site leadership and organizational levels
Strong understanding of GMP compliant Quality Control operations within a biotechnology setting
Experience with creating a robust environmental monitoring program
Experience with parenteral filling (sterile filling for vials, cartridges, and syringes) and/or Antisense Oligonucleotides
Demonstrated ability in developing and managing budgets and QC infrastructure
Proven track record of successful cross-functional collaboration and project management
Expertise in laboratory systems, analytical methods, and compliance with regulatory requirements
Proficiency in data analysis, trending, and reporting within a QC framework
Preferred
Experience with strategic planning and execution in a global quality context
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (82)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
thecanadianpressnews.ca
2025-12-24
2025-12-24
Company data provided by crunchbase