Senior Director, Compliance: Alexion Pharmaceuticals,Inc.

Responsiblities:

The Director Compliance will have responsibility for ensuring sustained regulatory compliance of Alexion sites, managing and hosting regulatory inspections as well as managing the internal and external auditing programs. The incumbent will work with site leadership to implement programs to improve compliance in daily operations at Alexion sites. In addition, he/she will formalize and lead all preparation activities for regulatory inspections at Alexion sites US, including a formal inspection management program, final approval of audit responses and tracking of inspectional commitments. The incumbent will develop site wide training programs to ensure staff understanding of compliance and regulatory requirements. He/she may also ensure that tracking systems are in place to ensure on time submission of CMC documents to support international filing requirements. The incumbent will analyze data and prepare technical summaries for a variety of reports. The Director Compliance will develop a nd maintain information systems for tracking and trending compliance status and will provide recommendations to Senior Management for strategies to mitigate compliance risks. He/she will provide leadership and training to staff members in the Compliance team.

• Implements programs to improve knowledge and understanding of compliance requirements at all levels in the organization. Identifies compliance gaps and develops and implements plans to resolve issues and mitigate risks.
• Leads all efforts to ensure inspection readiness of all Alexion US facilities including hosting consultant visits, preparation activities and managing PAI project plans.
• Provides strategic direction for risk-based internal and external audit programs for all Alexion sites and contract manufacturers. Ensures adherence to a pre-approved audit schedule and ensures auditor qualifications allow accurate assessments of site compliance and risks.
• Hosts and manages all Alexion US regulatory inspections, including managing inspection logistics, providing strategic direction to staff to defend practices, final approval of inspection responses and tracking corrective actions to closure. Implements tools to ensure tracking of post inspectional commitments and ensures on time completion.
• Provides guidance to all Alexion US facilities on interpretation of international regulations and provides regular updates on industry trends and their application to Alexion sites. Implements corrective actions as required.
• May provide review and approval of CMC sections for regulatory IND submissions, amendments and annual reports, as needed.
• Provides guidance to site related to significant deviation events that may impact compliance status or require regulatory notifications. Leads failure investigations and provides recommendations regarding quality system improvements.
• Leads investigations that may require reporting of Biological Product Deviations and ensures appropriate investigation, reporting to regulatory agencies and corrective actions.
• Facilitates and oversees development and continuous improvement of compliance initiatives. Manages development and maintenance of information systems for tracking and trending pertinent compliance data for quality system performance and/or improvements. Prepares technical summaries to effectively communicate status to Senior Management.
• Provides direction and leadership to staff to ensure timely completion of inspection preparation activities and adherence to audit schedules. Establishes realistic goals and objectives. Plans and directs work activities, and continuously monitors progress such that responsibilities goals and objectives are accomplished efficiently, completely and within established timeframes. Assures that work is performed in compliance with department SOPs and cGMPs.
• Facilitates the development and maintenance of a GMP Compliance Training Program (procedures, records) and ensures that site wide training is conducted to support inspection readiness.
• Interacts effectively with site and company management and internal departments to ensure compliance requirements are understood and adhered to.
• Assists and advises the VP Quality as required. Provides recommendations and input regarding departmental policies, procedures, goals and objectives. Fills in for VP Quality as required, fulfilling appropriate responsibilities and making judgments and decisions in a sound logical manner.

Requirements

• Bachelors degree in Biology, Chemistry, or related field or with 8 to 10 years experience in a biotech environment and 10 years leadership experience in a QA/Compliance or CMC related role
• Thorough knowledge of international regulatory requirements for biotech products and extensive experience in interactions with regulatory agencies.
• Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals.
• Team-oriented approach to project management and problem resolution.

About Alexion Pharmaceuticals

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Employing more than 500 people worldwide, Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris^(R) (eculizumab) is Alexion's first marketed product for patients with paroxysmal noctural hemoglobinuria (PNH) a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, and a 401(K) plan.

Alexion is an Equal Opportunity/Affirmative Action Employer.