Job description

Reporting to the Senior Vice President of Global Regulatory Affairs and Quality Assurance, this position will serve as an in-house champion on GxP compliance as well as establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day). If remote, you will be required to work in the SSF office one week/month.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Strategic Leadership:

Develop and execute a global quality strategy aligned with corporate goals and regulatory
requirements
Drive a culture of quality excellence, compliance, and continuous improvement across the
organization
Act as a key member of the clinical leadership team, providing strategic insights on quality-related matters impacting clinical development, regulatory submissions, and commercialization

Compliance and Oversight:

Ensure compliance with global regulatory standards, including FDA, EMA, and ICH guidelines
Oversee the design, implementation, and maintenance of Quality Management Systems (QMS)to support clinical development and manufacturing activities
Lead preparation for, and responses to, regulatory inspections, audits, and interactions

Operational Excellence:

Establish and monitor quality metrics to identify trends, assess risks, and implement proactive
solutions
Lead the QA oversight of clinical trial activities, including Good Clinical Practice (GCP) compliance audits of sites, vendors, and internal systems
Oversee Good Manufacturing Practice (GMP) activities for drug manufacturing, ensuring product quality and supply chain integrity

Team Leadership and Development:

Build, manage, and mentor a high-performing global QA team
Promote collaboration across Clinical, Regulatory, and Operations functions to achieve quality goals efficiently
Ensure appropriate resources and training are in place to maintain compliance and support corporate growth

REQUIREMENTS
Education

Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred)

Experience

Minimum of 15 years of experience in Quality Assurance, with at least 5 years in a senior leadership role in the pharmaceutical, biotech, or medical device industry
Proven track record in global QA strategy development and implementation
Comprehensive knowledge of GCP, GMP, GLP, and global regulatory requirements
Leadership Skills
Strong ability to influence and lead cross-functional teams
Highly diplomatic
Flexible thinking and pragmatism
Experience developing and mentoring high-performing teams in a global environment

Technical Skills

Expertise in regulatory inspections and audits

Strong analytical and problem-solving skills, with a proactive and results-oriented
mindset

Expert knowledge of GMP, ICH/GCP, and GLP FDA regulatory requirements; previous experience in APAC preferred

Familiarity with discovery data integrity policies and quality assurance a plus

Have strong technical skills, both functional and non-functional, manual and automation, ideally in a continuous delivery environment

Demonstrated success in making informed decisions for the department

The ability to prioritize and handle multiple activities daily yet flexibility and responsiveness to frequently shifting priorities

Demonstrated ability to positively integrate into a team environment (US, APAC)

Strong sense of ethics and honesty

Collaborative in partnerships with Project Teams and individual team members

Be an advocate of QA, Continuous Improvement, and industry-recognized Best Practices

Excellent knowledge of Risk Management, Risk Identification, and Risk-based Testing

Excellent communication, influencing, and negotiation skills to get management buy-in on ideas and concepts

Ability to communicate with all levels of management and peers within the organization

Ability to build, implement, and direct quality assurance principles and maintain the quality of delivery