Site Investigations Lead, Quality Assurance

Job Description

This position is a full-time on-site role (M-F business hours)

About This Role

The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations processes to ensure execution of an effective and compliant process with global and site procedures for the Biogen, RTP, Bio facility. The SIL will have leadership experience and capabilities to influence, impact, and collaborate with all levels of the organization to achieve meaningful outcomes. Responsibilities include but are not limited to: providing quality direction to the business to ensure efficient and effective execution of the exceptions processes, support review and approval of deviations, lab investigations, CAPAs, and change controls for compliance to applicable regulatory and corporate guidance documents, support the generation of metrics, develop and perform training methodologies to improve capability and competency of investigators and approvers, identify gaps and improvements in existing Quality systems and propose and implement solutions.

What You’ll Do

• Support and approve RTP Bio site exceptions (deviations, lab exceptions, CAPAs) and change controls 
• Serve as the Investigations Subject Matter Expert, supporting the site globally and participating in internal and external inspections 
• Supports resolution of complex technical and compliance issues/gaps of diverse scope 
• Develop and deliver training methodologies to improve capabilities of investigators and approvers 
• Develop, monitor, and review metrics and action plans for investigations program 
• Implement and facilitate meetings and communications related to the investigations program 
• Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure safety, efficacy and purity of products manufactured by Biogen 
• Additional job duties that may be assigned from time to time 

Qualifications

Required Skills

• Minimum Bachelor's Degree required in Life Sciences or other technical discipline 
• Minimum 10 years’ experience directly related to position responsibilities, working within a quality GMP biotech or biopharma environment 
• Knowledge of relevant FDA/EMA regulations 
• Advanced knowledge and training in exceptions management and root cause analysis tools 
• Demonstrated leadership abilities, can lead complex problem-solving initiatives across functions and serve as a decision maker within area of expertise 
• Proven ability to develop innovative/creative solutions for issues of moderate to challenging complexity 
• Must be able to deal with ambiguity 
• Detail oriented aptitude 
• Excellent oral and written communication skills; ability to communicate with all levels of the organization 

Preferred Skills

• Knowledge of QC testing, out of specifications, and anomalous results investigations preferred  

Additional Information

The base salary range for this position is $124,000- 166,000 annually. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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

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 en