Americas - Strategy Lead-GQ-CTampS Audits and Inspections

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Global Quality, Clinical Trials & Safety (GQ-CT&S) is responsible for the quality governance and auditing of clinical trials and safety. GQ CT&S defines the Clinical Quality Management Systems (QMS) enabling strategies and technologies and coordinates Quality Risk management at the compound and process levels to inform the audit focus and drive implementation of Quality Risk Management. GQ CT&S audits all processes related to clinical research and pharmacovigilance, including investigator site, country, process, vendor and partner audits, to assess compliance with relevant regulations and applicable policies and procedures. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements. GQ CT&S also offers support as Subject Matter Expert (SME) during Due Diligence and if areas of serious non-compliance are identified.

Purpose/Objective of the job

The Americas Strategy Lead will work in the GQ CT&S Audits and Inspections group. This group audits all processes related to clinical research and pharmacovigilance.

This role reports to the Americas regional management within global GQ CT&S Audits and Inspections structure.

The key objectives of this position are;

Conduct Good Clinical Practice (GCP) audit and support Pharmacovigilance (PV) Audits as required

Coordinate/lead/host Health Authority inspections

Line management responsibility for some CT&S auditors in the Americas region

Regional GCP compliance expert on related matters for R&D Management; provide strategic input and advice on evolving regional regulatory requirements, business and industry standards to stakeholders as well as the GQ-CT&S management.

Support the GCP audit strategy development in the Americas region, as well as drive the implementation and management of the Americas audit planning / program.

Maintain Business Intelligence in the regions of GCP regulatory requirements and industry standards, through external focus;

Key Responsibilities and Major Duties

Recruits, trains and directly supervises professional audit staff, consistently developing people through coaching and performance assessment, training or other experiences that broaden staff expertise;

Allocates regional resources in most efficient manner to drive the execution of the audit strategy;

Collaborates with the Global CT&S Strategy or Risk assessment Roles to achieve the optimal study and vendor audit strategy in Americas region, in accordance with company objectives, and in consultation with regional R&D Leadership (clinical, operations, regulatory);

Act as an expert resource/trainer for GQ-CT&S; as a credible, influential and respected spokesperson on matters pertaining to compliance both within and outside of the BMS organization;

Reviews results/analyses of GCP audits in the Americas region, including audits of clinical investigator sites, vendors, internal systems to assess regulatory compliance, and where appropriate, escalates issues with BMS management to ensure proper follow up and resolution;

Lead GPS and/or BMS company process- and improvement initiatives;

Perform GCP and support PV audits (as required) including audits of clinical investigator sites, vendors and internal systems to assess regulatory compliance; apply audit principles, procedures and methods; maintain the audit and inspection database as required

Represent GQ-CT&S on Due Diligence activities for vendors

Lead or co-lead compliance Investigations, as assigned;

Act as a liaison with key stakeholders and provide input into related audit strategy and plans, GPS and /or BMS company processes; e.g. PEARL team member or specific initiatives;

During audits, evaluate key GCP processes to determine compliance with regulatory requirements and established standard operating procedures;

Maintain an in-depth knowledge of governmental regulations impacting research and development of medicines.

Collaborates with Regulatory and Compliance Roles within the region to understand and mitigate risks related to clinical trials in co-development partnerships; Provides expert advice and guidance to local teams in the countries with regard to any issues related to GCP including reporting requirements, mitigation and CAPA management;

Closely follows the rapidly changing Regulatory environment in the applicable region, business and industry standards and assesses the associated risks and associated processes. Subsequently proposes and develops strategic mitigation steps or process changes to the Senior Leadership Teams; such as proposing and developing regional-specific audit and inspection methodologies to enhance the regional audit strategy and selection;

Coordinate key, high risk HA inspections, as assigned. Lead complex and simultaneously execute Health Authority Inspection activities in the Americas region, involving multi-disciplinary teams; and being the primary point of contact for the Health Authority inspectors. Lead the preparation/review of responses to inspectors through multi-disciplinary input and leading the post-inspection activities. This includes the training of multi-disciplinary teams prior inspection, leading lessons learned sessions while identifying opportunities for improvement and drive process changes to mitigate risks;

Review and assess corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence; escalate CAPAs and ensure the direct reports are escalating as per procedural documents;

Support the integration of newly hired GQ CT&S staff in the Americas region through mentoring, as assigned;

Support GQ CT&S management in the hiring process of new GQ CT&S Americas staff through direct interaction and evaluation of selected candidates;

Support the Quality Governance and Risk Assessment team in the creation and maintenance of project study plans while preparing for and after audit conduct of investigator site audits;

To manage the Tier 3 Quality Council as indicated by upper management;

Represent GQ-CT&S position during internal and external meetings;

Act as an advisor and back-up to the Director of GQ-CT&S Americas

Supervise 2-5 Direct Reports

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be required as assigned)

Supervisory Responsibility

Supervise audit staff (from different levels varying from D4-D6), where indicated

Key Stakeholders/Contacts

GQ-CT&S Management; audits and inspections /Quality Governance and CAPA.

(Co-) Auditors GQ CT&S

Internal stakeholders; e.g. technical, supervisory and management personnel

External stakeholders: e.g. vendors, investigator sites

External auditors and inspectors during the conduct of Health Authority inspections

Applicable GPS, GCO and GRS&B personnel, related to initiatives or processes for which the incumbent is involved as the lead or as the GQ CT&S Subject Matter Expert.

List of minimum requirements

Degree/Certification/Licensure: University Graduate, Life Sciences degree preferred.

Experience – Responsibility and minimum number of years

Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at least 10 years in the pharmaceutical industry or equivalent and 6 years in quality management, including GCP auditing and/or related experience. Risk Assessment expertise required; Experience supervising others or leading teams.

Competencies – knowledge, skills, abilities, other

Effective verbal and written communication skills in English. Ability to adapt communication style to suit different audiences/cultures. Deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients;

Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management, during the audit, inspection or process improvement process;

Ability to participate in the critical evaluation of quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations;

Good presentation skills, deliver focused message to audience of peers, stakeholders and Regulatory Agency Inspectors;

Profound knowledge of quality risk management. Ability to identify and escalate areas of high risk;

Demonstrates commitment to delivering high-quality work product;

Knowledge of relevant BMS policies and procedures;

Profound knowledge of regulatory requirements for clinical research and development;

Good understanding of the drug development process;

Develops strong working relationships with key stakeholders.

Ability to analyze complex situations, and to draw meaningful conclusions, by distinguishing the details from the essence of the issue;

Ability to discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;

Maintains the confidentiality and security of information, data, documents and records;

Able to function independently within an environment that relies heavily on technology for information and communication;

Sense of diplomacy and discretion;

Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;

Fluent in English and other languages, as applicable to assigned audit region;

Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;

Ability to manage competing priorities;

Ability to lead change processes within functional group;

Possesses detailed knowledge of areas of expertise and could teach or mentor others;

Develops and applies new methods and ideas to enhance performance

Demonstrates computer literacy; Microsoft Suite, SharePoint, Veeva Vault, other systems as assigned/applicable

Working Conditions

Travel Required

Approximately 25% travel (domestic and international) to perform audits and attend professional meetings and seminars.

Overnight Absences: Approximately 5 overnight absences per month.

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

Will work inside of hospitals, laboratories and pharmacies while performing audits and inspections.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com