Global Quality Assurance Auditor, Pharmacovigilance

GE HealthCare (United States); United States; Remoto; USD 102.000 - 153.000; Tempo pieno

Vantaggi offerti da questo lavoro

Tuition reimbursement

Benefits package

Descrizione del lavoro

GE HealthCare is seeking a QA Auditor for Pharmaceutical Diagnostics (PDx) focused on GMP manufacturing and Pharmacovigilance (PV) compliance. The role emphasizes audits, regulatory oversight, and continuous improvement across global sites.

The position requires experience in pharmaceutical auditing, regulatory interfaces, and CAPA management, with ongoing monitoring of MHRA, FDA, and EMEA guidelines. Collaboration with cross-functional teams is essential.

Competenze

• Auditing experience in pharmaceutical industry and quality systems.
• Ability to interpret and apply regulatory expectations from MHRA, FDA, EMEA.
• Strong communication and collaboration skills across global stakeholders.

Mansioni

• Plan, prepare and execute internal and external audits for QRA.
• Ensure corrective actions are remediated in a timely manner and reviews completed for effectiveness.
• Analyze risks and propose process and functional audits with stakeholders.
• Support regulatory inspections and customer audits as QA SME.
• Conduct trend analyses of audit data and share insights with stakeholders.
• Oversee vendor qualification and surveillance per global procedures.
• Contribute to QMS improvements and CAPA management.
• Stay updated on evolving regulations and assess impact on procedures.

Conoscenze

Auditing experience

Regulatory knowledge

Communication skills

Formazione

Bachelor's degree in related field

High school diploma with 8+ years pharmaceutical experience

Descrizione del lavoro

Job Description Summary

This role is responsible for providing QA auditing for the Pharmaceutical Diagnostics (PDx) business. This role will have a focus on auditing and Global Compliance support to the GMP manufacturing sites and Pharmacovigilance (PV) related functions. Suitable candidates should have experience in the Pharmaceutical industry.

The role will perform audits on behalf of CQA with a focus on PV. In this role insights and industry trends are to be proactively shared within the organization to ensure continued compliance and early identification of areas for continuous improvement.

This role will provide analyses of audits / trends and support in the assessment and promotion of compliance within PV QA. This role will be aware of changes to regulations, guidelines, and provide support and QA oversight for any necessary updates to operating procedures, risk assessments and change controls for process changes as well as productivity / efficiency improvement initiatives.

Roles and Responsibilities

• Support a program (plan, prepare and execute) of internal and external audits for QRA.


• Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity.


• Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits.


• Support regulatory inspections and customer audits as a functional QA subject matter expert.


• Conduct trend analysis of audit and other quality related data, provide to internal / external stakeholders as agreed.


• Assure completion of vendor qualification and surveillance activities performed and documented as defined in global and functional procedures.


• Participates in the quality management system (QMS) improvements.


• Provide guidance and ensure that 'CAPA's are correctly set up to capture risk assessment, effective corrective and preventive actions and have the required evidence. Perform QA approvals of Quality Event records.


• Keep up to date with latest guidelines from MHRA, FDA, EMEA and other Regulatory bodies. Monitor legislation, implementing changes, and informing the company of any relevant changes.


• Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned.

Required Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 8 years of experience in pharmaceutical industry.)


• 6+ years of experience in the pharmaceutical industry


• Previous Auditing experience required.


• Experience interfacing with global regulatory agencies.


• Ability to comprehend and communicate key regulatory requirements and expectations


• Experience in collaboration, negotiation & conflict resolution skills


• Knowledge of GPvP, cGMP, and GDP

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.


• Demonstrated experience with applying classic Quality tools


• Experience interfacing with global regulatory agencies


• Change agent with energy, passion & enthusiasm to drive change


• Demonstrated effective interpersonal, teamwork & networking skills


• Ability to influence. Determine a position and argue it effectively within the business context.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $102,320.00-$153,480.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

Wh