Senior Manager Manufacturing - Deviation Investigations

BioSpace; Holly Springs (NC); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive Total Rewards Plans

Equal opportunity employer

Support for professional growth

Job summary

A leading biotechnology company in Holly Springs is seeking a Senior Manager Manufacturing - Deviation Investigations. In this role, you will provide strategic leadership overseeing deviation investigations and a team of investigators. Responsibilities include managing compliance, documentation accuracy, and cross-functional collaboration. The ideal candidate will have extensive experience in quality and manufacturing combined with strong leadership skills. Competitive benefits offered.

Qualifications

• 12 years of Quality and/or Manufacturing experience.
• 8 years of Quality and/or Manufacturing experience with Bachelor's degree.
• Strong background in compliance and root cause analysis.
• Experience leading investigation teams and regulatory interactions.

Responsibilities

• Lead the Major Investigation Writing Team.
• Oversee documentation for accuracy and compliance.
• Serve as point of contact for critical investigations.
• Ensure investigations meet regulatory and quality standards.
• Drive CAPA and continuous improvement initiatives.

Skills

Leadership

Problem-solving

Compliance

Technical writing

Cross-functional collaboration

Written communication

Cross-functional collaboration

Education

High school diploma / GED

Associate's degree

Bachelor's degree

Master's degree

Doctorate degree

Tools

Quality Management Systems (Veeva, TrackWise)

Quality Management Systems (TrackWise)

Job description

Senior Manager Manufacturing - Deviation Investigations

Join to apply for the Senior Manager Manufacturing - Deviation Investigations role at BioSpace

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single-use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager Manufacturing Deviation Investigations

What You Will Do

Lets do this. Lets change the world. In this vital role, you will provide strategic and operational leadership for the Investigations function at ANC. You will oversee a team of Level 5 Investigators and ensure investigations meet regulatory and quality expectations while driving a culture of compliance and continuous improvement.

• Lead the Major Investigation Writing Team responsible for high-complexity deviation investigations within ANC's Drug Substance Flex Batch Manufacturing operations.
• Provide direct management, coaching, and development to Level 5 investigators, fostering strong technical writing, problem-solving, and critical thinking skills.
• Ensure investigation quality and consistency, overseeing documentation for accuracy, compliance, and readiness for regulatory inspection.
• Establish best practices, standardized processes, and metrics to continuously improve the deviation investigation system.
• Serve as the point of contact for escalation of critical investigations and communicate investigation outcomes to site and global leadership.
• Present investigations and findings to regulatory inspectors, internal auditors, and senior leadership.
• Partner cross-functionally with Manufacturing, Quality, Engineering, Process Development, Analytical Sciences, Supply Chain, and Regulatory Affairs.
• Influence site-wide decision-making on deviation management strategies and corrective/preventative actions (CAPAs).
• Drive strategic projects to enhance efficiency, knowledge sharing, and compliance in deviation investigation processes.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The management professional we seek is a vital with these qualifications.

Basic Qualifications

• High school diploma / GED & 12 years Quality and/or Manufacturing experience OR
• Associate's degree & 10 years of Quality and/or Manufacturing experience OR
• Bachelor's degree & 8 years of Quality and/or Manufacturing experience OR
• Master's degree & 6 years of Quality and/or Manufacturing experience OR
• Doctorate degree & 2 years of Quality and/or Manufacturing experience

Preferred Qualifications

• 8+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Prior people leadership experience, managing and developing a team of investigators or equivalent technical staff
• Strong background in compliance, root cause analysis, problem-solving, and CAPA management
• Experience using Quality Management Systems (e.g., Veeva, TrackWise) for deviation investigations
• Proven track record of leading teams through regulatory inspections and audits
• Excellent organizational skills, with ability to manage multiple priorities and deadlines in a fast-paced environment
• Exceptional written and verbal communication skills with the ability to influence at all organizational levels
• Strong interpersonal skills and demonstrated success in cross-functional collaboration

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.