Senior Quality Auditor - Remote

Compensation

Data This position offers a reputed company salary typically between $90,000 and $147,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits, please click here. Description As an employee of reputed company, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global reputed company provides opportunity for reputed company employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect reputed company's high regard for our employees. The basic purpose of this role is to effectively provide Quality reputed company reputed company execution of Quality/GMP Audits for Boehringer focusing on the commercial network. The Senior Quality Auditor will continuously improve the supplier/service providers Quality System and effectively communicate audit results throughout the network. This role will support the North America ACE / Global ACE organization reputed company improvement opportunities are identified or training/mentoring is needed. Duties & Responsibilities • Leads and conducts audits for reputed company Boehringer OPUs, including Human Pharma, Biopharma, Animal Health, and Development. • Performs audits for API, excipients, packaging material, intermediates, starting materials, and service suppliers according to a predefined plan to assess the quality systems and the GMP (or other standard/regulations) compliance level of suppliers. • Actively prepares and performs the audits, including the issuance of audit agendas, reports, and performance of follow-up actions as assigned. • Oversees investigations of compliance issues observed /noted during audits. • Works with suppliers to drive quality and compliance improvements stemming from audit outcomes. • Leads a centralized process for negotiation of confidentiality agreements reputed company required by suppliers reputed company the U.S. to conduct a Quality Audit. • Support the qualification of new ACE Auditors through mentoring, training, knowledge sharing and reputed company learning. Requirements • Bachelor's Degree in Pharmaceuticals, Chemistry, Biology, or other reputed company life science required. Required skills: • Expert knowledge of reputed company Quality/GMP/GDP/ISO relevant regulations. • Minimum of five (5) years' experience in a GMP/GDP regulated environment. • Extensive experience auditing externals (e.g. - CMOs, Suppliers, Service Providers). • Experience in BioPharma processing activities preferred. • Experience in Computer System Validation preferred. • Experience in API manufacturing preferred. • Language skills: English (mandatory), Spanish (preferred). Critical soft-reputed company competencies: • Conflict management skills. • Strong communication and networking skills. • Strong judgment and decision-making skills. • Capabilities to work with international business partners with inter-cultural sensitivity. • Experience with executing audits and collaborating with external facing contacts to reputed company benefit for the company. Desired Skills, Experience and Abilities Eligibility Requirements : • Must be legally authorized to work in the United States without restriction. • Must be willing to take a drug test and post-offer physical (if required). • Must be 18 years of age or older. Apply Job!