- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- By providing a foundation for all operations company wide, our company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases.
- Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology.
- Come join our team and make a meaningful impact on patients’ lives.
- Our company is a global, high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, self-motivation and organization are essential role requirements.
- This position will play a key role in executing company’s GMP Compliance Program.
- The overall purpose of this program is to ensure continuous compliance with applicable global GMP/GDP regulations and company quality requirements through periodic assessments of internal operations; domestic and international third parties (i.e. suppliers, contract manufacturers, contract laboratories, commercial distribution partners and key service providers) responsible for providing materials and services for the manufacture of GMP regulated clinical material and commercial finished products.
- The primary responsibility of the position is the planning and execution of audits to assess ongoing compliance with government regulations and corporate standards of company suppliers and internal sites.
- All employees are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first time performance.
- Prepare and lead GMP audits across multiple internal sites and third parties both domestic and international.
- Identify compliance risks and develop sound rational for observations against current regulatory requirements and standards.
- Provide timely audit reports, timely data entry into the data tracking systems and evaluate corrective action plans.
- Assist in the development and training of audit team members.
- Develop and improve compliance processes, integrate global systems and provide related training to stake holders as necessary.
- Serve as an internal consultant in interpretation of regulatory requirements and expectations.
- Represent Compliance in various forums and project teams.
- Other duties as assigned.
- Must have wide-ranging and broad GMP compliance experience complimented by an ability to use skills to contribute to development of company objectives and principals and to achieve goals in creative and effective ways.
- 8 - 12 years of experience in pharmaceutical, biotech and/or medical device industry.
- Experience in sterile operations is highly desirable.
- 3 - 5 years compliance auditing experience.
- Knowledge of GMP and GDP regulations (US, EU and Japan) and related guides and standards.
- Demonstrated lead auditor skills.
- Strong interpersonal skills, including excellent influencing and negotiating skills.
- Demonstrated ability to identify compliance issues and analyze effectiveness of proposed corrective and preventative actions.
- Flexible and team work approach.
- Project management and troubleshooting skills.
- Ability to communicate effectively both written and orally to all levels of management and across different cultural backgrounds.
- Language skills in addition to English a plus.
- BS in life sciences or engineering preferred, but other technical/scientific areas or equivalent education/experience combinations will be considered.