This Position reports directly to the Manager, QA Compliance
The Compliance Auditor IV will be responsible for the coordination and preparation of internal and external audits and compliance in accordance with international GMP/GDP requirements and Alexion Quality standards. External audits include raw material and component suppliers, contract manufacturer’s (API and fill finish facilities), contract laboratories, labelers and packagers, warehouses and distributors, some of which are located in other regions. This position collaborates with Alexion GMP areas, suppliers, and contract manufacturers to develop positive and proactive approaches to regulatory compliance; participates in good laboratory practices; training of functional areas and assists in the development of training sessions. The Compliance Auditor IV will be responsible for interpreting GMP regulations to perform GMP audits according to an approved global audit schedule. The incumbent will ensure timely issuance of reports, review of responses, follow-up on corrective actions and audit closure. A key responsibility will be to work closely with the QC organization to conduct audits to support the Vendor Qualification Program and with the QA organizations to conduct pre-assessment visits of potential third party business partners. Travel approximately 30-40% of the time with the majority of travel domestic in scope.
Approves new contractors: Drug Substance manufacturing, Fill/Finish and Packaging/Labeling of Drug Product, laboratories;
Approves new suppliers: raw material and commodity manufacturers, and service providers;
May drive final company decision on ‘conditional approval’ of a contractor or increase/decrease contractor/supplier surveillance frequency;
May drive removal decision of a contractor or supplier on the company’s approved supplier list;
Primary representative during regulatory agency audits for contractor or supplier audit and the on-going monitoring process;
Issues complaints to contractors or suppliers based on the internal investigation process and may be primary contact to the CMO or supplier for investigation and corrective action resolution;
Assembles audit teams with appropriate skills and experience and ensures audits of internal departments and external sites are performed according to approved global audit schedule;
Partners with QC, or other department, subject matter experts to conduct assessments and/or audits to support Vendor Qualification Program and contractor audits;
Leads or participates in internal audits of Alexion Rhode Island Manufacturing site and other Alexion sites to assess compliance to international GMP requirements and Alexion Quality standards;
Leads the preparation for and conducts audits of raw material, component suppliers and service providers for the Alexion Rhode Island Manufacturing site. May lead or participate in audits of contract manufacturers, labelers/packagers, contract laboratories and distributors to evaluate processes, systems and procedures for compliance to cGMP requirements and Alexion Quality standards. Assigns responsibilities to audit team members and provides audit preparation materials, instructions and training as appropriate;
Ensures timely issuance of audit reports and follow-up on responses and corrective actions. Tracks completion of activities from scheduling through audit closure;
May perform for cause audits of business partners to assess regulatory risk and propose recommendations to senior management;
Partners with local QA teams to coach and train staff on regulatory requirements, provide visibility to current agency trends and maintain compliance of Alexion sites;
Maintains in-depth knowledge and understanding of current regulations and guidelines that apply to the types of facilities and functions being audited as well as applicable jurisdictions;
Interacts effectively with management of 3 rd parties as well as management and peers of internal departments. Utilizes a collaborative approach to auditing and provides recommendations to auditees to maintain GMP compliance;
Assists and advises the Manager, QA Compliance, as required. Provides recommendations and input regarding compliance of internal department systems, procedures, investigations, etc. Fulfills appropriate responsibilities and making judgments and decisions in a sound logical manner;
May create or revise standard operating procedures relating to inspection readiness, internal audit program, supplier monitoring, supplier audit program, and other related documentation;
May coordinate activities and assists with interactions during regulatory agency inspections;
May direct interaction with regulatory agencies on defined matters;
Assists with the corrective action implementation;
Performs other duties as required.
8 - 12 years demonstrated practical experience in auditing GMP facilities for the biotech/pharm. industry or related experience; and sterile GMP facilities is required;
Thorough knowledge of cGMP/GDP and international regulatory requirements is essential;
B.S. degree in Chemistry, Biology or related field
Works on complex problems in which analysis of situations or data requires an evaluation of intangible variables;
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results;
Acts independently to determine methods and procedures on new assignments and may provide guidance and oversee audit preparation or remediation activities;
Candidates must possess effective interpersonal, written and verbal communications skills, along with a team-oriented approach to project management and problem resolution.
Ability to travel both domestically and internationally
Alexion Pharmaceuticals, Inc. (Alexion) is a biopharmaceutical company engaged in the discovery, development and delivery of biologic...