Associate Director, Compliance Jobs

• Define the Compliance strategy to support business requirements.
• Maintain policies, standards and procedures for the Compliance functions.
• Lead a Compliance team.
• Develops and manages training for Auditors, and external inspection support staff
• Support GMP system, and process improvement initiatives. Lead continuous process improvement within Quality, by providing directives, and representation on project work-streams as required.
• Responsible for Compliance including Audits and Inspections, Client Communication and Regulatory.
• Supports Quality management contact with the FDA, EMA, and other regulatory authorities worldwide, as well as partners regarding quality issues including field alerts, recalls, or regulatory actions.
• Facilitates and coordinates Client audits and regulatory agency inspections
• Sets the requirements for the Self Inspection Program
• Develop a pool of internal auditors
• Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
• Defines the Self Inspection Schedule
• Responsible for training of Compliance team members. Business Process Owner for Audits and Inspections
• Develop and maintains the Inspection Readiness Program
• Supports other GXP functions as required.

• Sound organizational skills
• Solid understanding of quality management systems and continuous process improvement principles including global cGMP requirements and other relevant regulations and guidance to assure quality products
• Certification/training in applicable quality management disciplines preferred
• Experience in aseptic technique/operations, clean room procedures/processes, environmental monitoring programs, and media simulation studies
• Experience with cell therapy processes
• Ability to present clearly using scientific and clinical terminology
• Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals
• Master of Science (M.Sc.) or PhD with 8+ years of applicable industry experience; or
• Ability to anticipate and resolve problems effectively
• Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
• Experience with cGMP, manufacturing, and testing requirements as they relate to biologics
• Expertise in the cGMP requirements pertaining to sterile drug product manufacturing operations in the United States and globally in support of global clinical and commercial production activities
• 6+ years of direct or indirect management experience
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
• Strong verbal communication and technical writing skills
• High school diploma with 15+ of applicable industry experience
• Motivates team members, fosters and nurtures teamwork
• Strong scientific/technical skills
• Associate Degree with 12+ years of applicable industry experience; or
• Experience with commercial facility pre-approval inspection (PAI) and PAI readiness planning
• Role model for company core values of trust, delighting our customers, Gemba, and Genki
• Bachelor of Science (B.Sc.) with 10+ years of applicable industry experience; or

Salary and Benefits

• 401k
• Medical, Dental, Vision
• Paid Time Off
• $165,000 to $180,000 per year, depending on experience.
• Life Insurance

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.