Senior Specialist, Quality Compliance Global API

2 weeks ago

Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

Ireland is home to External manufacturing's global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO's) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.

This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

The Role

Bristol Myers Squibb is looking to recruit on aFixed Term Contract, Senior Specialist, Quality Compliance Global API to manage compliance and regulatory requirements for Global API Quality Operations group in External Manufacturing Quality.

Key Duties and Responsibilities:

Manage / track the API Quality Agreement program to ensure regulatory compliance Engage with internal and external stakeholders to prepare, negotiate and organise approval of Quality Agreements with Internal Sites, including those associated with multiple Bristol Myers Squibb (BMS) parties Manage the BMS Fact Finding (FF) process for major investigations involving Global API Contract Manufacturing Organisations (CMOs) & products. Work with the Quality Services Lead to coordinate the compilation of the information for presentation to senior management in support of the FF process Manage compliance program for Global API quality group Manage/track the annual CMO Risk Assessment process, working with Quality Operations Managers and the Global Quality Auditing group to achieve timely completion of the assessments Manage the Global API Quality Operations metrics programs in relation to CMO performance. Report out on this at group meetings, quality council and develop action plans as required Compile and deliver the monthly Tier 3B Quality Council in line with site procedures. Engage with Manufacturing, Science and Technology (MS&T), Regulatory Compliance, Quality Operations team, etc., as required for content. Escalate items as appropriate to the Tier 3A Quality Council Manage / track compliance of Global API CMO's to Wholesale Distribution Authorisation (WDA) and ensure Bona fides are completed as per Good Distribution Practice (GDP) regulations. Be subject matter expert (SME) within Active and Intermediate (A&I) group for compliance to WDA and GDP regulations Work with quality operations managers, MS&T and CMO's to manage Quality Operations compliance to the Annual Product Quality Review (APQR) procedure and overall program Develop, and update standard operating procedures (SOPs), Work Instructions as applicable. Manage gap analysis of site SOPs, as well as engaging with corporate quality functions to identify gaps in quality directives / policies / global Health Authorities (HA) observations as the SME for Quality Operations Global API to ensure gaps are mitigated Provide Good Manufacturing Practice (GMP) Health Authority inspection support (preparation, back-room support, etc.) and subject matter compliance expertise for Global API quality group. As part of extended External Manufacturing team Support Regulatory inspections of External Manufacturing Review new regulatory and emerging guidelines to assess impact to External Manufacturing operations, and provide training to staff as appropriate Manage/track the progression and close out of Regulatory actions associated with External Manufacturing Change Controls (Global API) Track the progression and close out of Deviations / Corrective Actions and/or Preventive Actions (CAPAs), Effectiveness Checks, Standalone Action Manage Regulatory documentation request to support filings, updates, renewals and HA requests, where applicable Act as API representative for compliance related topics on cross functional teams as required Work with the Virtual Plant Teams (VPTs) to put in place a system for managing and tracking the stability programme at CMOs to ensure compliance with Regulatory requirements Carry out batch release as required.

Qualifications, Knowledge and Skills Required:

Greater than two years' experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority Agency Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development In depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically the Food and Drug Administration (FDA) and/or European Medicines Agency (EMA) Direct experience in interacting with external manufacturers and supporting quality at external manufacturing sites Ability to assess the right balance between business targets and scientific and quality decisions Strong analytical and problem solving skills Strong project management and organizational skills The ideal candidate should hold a chemistry, chemical engineering or Pharmacy qualification with a minimum of two (2) years' experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency

Why you should apply

You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

BMSBL

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