Associate Director, Quality Control Compliance

BeOne Medicines; Hopewell (NJ); On-site; USD 134,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Wellness program

Job summary

BeOne Medicines seeks an experienced Associate Director, QC Compliance at our Hopewell, NJ site. You will lead QC compliance programs, oversee investigations for OOS/OOT/OOE, and drive cGMP adherence across large and small molecule manufacturing and testing.

Collaborate with Regulatory Affairs, Manufacturing and QA to support submissions, CAPA planning, and continuous improvement. This senior role requires a BS with 8+ years in FDA-regulated environments and 5+ years of people leadership.

Qualifications

• BS in a science or related field required for FDA-regulated manufacturing.
• MS preferred for advanced roles and seniority.
• Minimum 8+ years in a FDA-regulated biotech/pharma environment.
• 5+ years of managerial experience directing teams or projects.

Responsibilities

• Develop, implement, and maintain QC compliance programs in line with regulatory standards and internal policies.
• Lead investigations for OOS, OOT, and other deviations with thorough evaluations.
• Prepare and write SOPs, compliance reports, deviation and CAPA records, and change control assessments.
• Lead internal and external GMP audits to ensure laboratory compliance with standards.
• Collaborate with QA, Regulatory Affairs, Manufacturing to support regulatory submissions and initiatives.
• Mentor QC compliance staff and promote professional development.
• Participate in risk assessments and develop CAPA plans to address issues.
• Communicate and train staff on compliance standards and regulatory expectations.

Skills

Quality Control compliance

GMP/regulatory knowledge

Leadership/mentoring

Regulatory submissions experience

Veeva/LIMS experience

SOP writing

Analytical/problem solving

Education

Bachelor of Science in a related field

Master's degree in related field

Tools

MS Office

LIMS experience

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

The Associate Director, QC Compliance will lead and manage all activities related to Quality Control lab compliance to ensure adherence to GMP guidelines in the manufacturing and testing of large and small molecule products. This role will focus on establishing QC compliance protocols, ensuring effective quality assurance processes, and maintaining regulatory compliance with FDA/EU regulations. The Associate Director will also support the development and implementation of compliance procedures and lead investigations related to compliance deviations. This role is located at the Hopewell, NJ site.

Essential Functions Of The Job

• Develop, implement, and maintain Quality Control compliance programs in alignment with regulatory standards and internal policies.
• Lead and manage laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and Other Exceptions (OOE) results, ensuring thorough evaluation and adherence to cGMP regulations.
• Oversee the preparation and technical writing of compliance-related documents, including SOPs, compliance reports, deviation and CAPA records, and change control impact assessments.
• Lead the establishment of a compliance monitoring program, including participation in internal and external GMP audits to ensure laboratory adherence to industry standards.
• Collaborate daily with Quality Assurance to maintain and improve the health of the quality management system.
• Collaborate cross-functionally with other departments including Regulatory Affairs, Manufacturing, and Quality Assurance to facilitate successful regulatory submissions and compliance initiatives.
• Champion a sustainable culture of quality, compliance, accountability, and continuous improvement across the QC organization.
• Guide and mentor QC compliance and review staff to enhance their capabilities, fostering a high-performing culture and promoting professional development.
• Actively participate in risk assessments and assist in developing CAPA plans to tackle any compliance issues or potential risks efficiently.
• Ensure effective communication and training regarding compliance standards and regulatory expectations across the QC laboratory team.

Core Competencies, Knowledge and Skill Requirements

• Bachelor of Science degree and 8+ years of relevant working experience in an FDA-regulated biotechnology or pharmaceutical manufacturing environment required.
• Master's degree and 6+ years of related scientific experience preferred
• 5+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
• Extensive knowledge of cGMP/EU GMP regulations and compliance, especially relating to large molecule manufacturing.
• Strong leadership and team management skills, with proven capabilities in mentoring and developing staff.
• Excellent analytical and problem-solving capabilities, with a track record of resolving complex compliance issues.
• Highly effective communicator, both written and verbal, capable of engaging with technical and non-technical stakeholders.
• Strong project and program management skills with experience directing multiple priorities within a fast-paced environment.
• Attention to detail and commitment to producing quality work, with the ability to work proactively and independently.

Supervisory Responsibilities

• Manage and mentor a dedicated team of 1-2 QC compliance professionals, including data reviewers.

Computer Skills

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
• Experience with Veeva and ThermoScientific LIMS is a plus

Travel

• Must be willing to travel approximately 20%
• Ability to work on a computer for extended periods of time

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $133,800.00 - $183,800.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].