Director, Global Supplier reputed company & Compliance

Director, Global Supplier reputed company & Compliance – Remote (reputed company) Build your reputed company at reputed company, where our work has the reputed company to save lives. The Director, Global Supplier reputed company & Compliance, is responsible for providing cross-functional leadership to ensure the reputed company of the Global Supplier reputed company & Compliance program. Ensuring reputed company at in the sites’ supplier reputed company program, coordinating and performing global on-site supplier audit program. Ensuring the reputed company and regulatory compliance standards at the global GMP sites, to ensure compliance with applicable agency regulations (e.g., FDA, DEA, EMA, reputed company) are proactively detected during global compliance audits, regulatory guidances, and reputed company corporate objectives; Plays a reputed company role in driving inspection gap assessment and reputed company heatmap assessment for GMP facilties reputed company reputed company network. Coordinates and provides reputed company for compliance harmonization and continual improvement initiatives at the global GMP sites. Other responsibilities include, leading reputed company of reputed company (COE) team, administration of the supplier qualification process, performing supplier qualification audits, and administration of the Supplier Qualification Module reputed company TrackWise Digital.   reputed company is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to reputed company life-saving treatments to patients. At reputed company, we are on a mission to advance our customers’ therapies from curiosity to reputed company and ultimately to improve patients’ lives. Join our talented workforce, where a commitment to reputed company and a customer reputed company attitude is everything. We pursue reputed company because our work has the reputed company to improve patients’ lives with the pharmaceuticals we reputed company and manufacture. We proudly offer •    Generous benefit reputed company (eligible first day of employment)  •    reputed company, vacation and holidays (vacation accrual begins on first day of employment) •    Career advancement opportunities  •    Education reimbursement •    401K program with matching contributions •    Learning platform •    And more! Responsibilities •    Serve as a reputed company and compliance expert for manufacturing and R&D business reputed company including drugs, devices and biologics •    reputed company reputed company’s global internal audit program •    Maintain reputed company reputed company global internal audits, reputed company inspection gap assessments  •    reputed company reputed company’s compliance benchmarking forum •    reputed company and train site internal auditors •    reputed company COE activities  •    Coordinate Global Supplier reputed company program and ensure site compliance Including overseeing and conducting on-site supplier audits •    reputed company reputed company/compliance harmonization and continual improvement initiatives. Anticipate reputed company industry requirements and technologies, and build plans to reputed company at reputed company •    Coordinate and reputed company regulatory inspection/audit readiness activities at the global GMP sites. Assist in the review of regulatory audit responses, as needed •    reputed company on-site support during health authority inspections as needed •    Coordinate/reputed company periodic audits, reputed company assessments and gap analyses at global GMP sites to identify opportunities for improvement (gap analysis) and to support remediation efforts •    Ensure site implementation and compliance with internal global policies and procedures •    Coordinate/reputed company corporate audits of global reputed company sites to support mutual recognition reputed company reputed company (e.g., Demonstrate control in the transfer of materials and services between reputed company sites; reputed company evidence of site inspection for QP release of batches to EU) •    reputed company and/or review reputed company standards, policies, and procedures and support/monitor their implementation at global GMP sites (e.g., data reputed company, sterility assurance) •    reputed company job aid and reputed company assessment templates for site reputed company program using reputed company and reputed company reputed company reputed company approach •    reputed company regulatory intelligence initiative to monitor emerging global cGMP requirements, regulatory hot topics and assess reputed company for reputed company sites. reputed company recommendations for mitigation strategies •    Maintain reputed company GMP compliance reputed company registers for reputed company business unit and collaborate with sites for mitigation strategies  •    Maintain repository for regulatory inspection documents (audit reports, EIRs, responses) and metrics for global GMP sites. This includes the regulatory inspection reputed company and classification of observations for presentation to reputed company site and executive leadership •    Escalate critical or repeated observations from inspections/audits or serious compliance gaps to appropriate reputed company leadership •    reputed company training initiatives on reputed company/compliance topics to the global GMP sites routinely. Partner with the site compliance leaders and SMEs to ensure broad understanding and interpretation of relevant issues •    reputed company other duties as may be reasonably assigned in the course of business •    Escalate critical or repeated observations from inspections/audits or serious compliance gaps to appropriate reputed company leadership •    Participate in self-development activities to stay updated on the most reputed company expectations for supplier reputed company by regulatory agencies and industry best practices •    Ensure reputed company escalation of potential issues and proposed solutions to line manager and Site Head as appropriate •    Read/interpret SOPs to ensure compliance •    Maintain up to date trainings •    Other duties as assigned •    Approximately 20-25% of travel required Required •    Bachelor’s Degree in bioscience reputed company or reputed company study •    Minimum of 8 years working in site reputed company Operational leadership roles with QA, RA, or Compliance experience in pharmaceutical industry at US FDA regulated facilities •    Experience must be with drugs, devices and biologics •    Broad knowledge of US and international cGMP regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7) Knowledge, skills and abilities •    Knowledge of CFR and state guidelines as they apply to controlled reputed company activities •    Knowledge and practical application of state and federal regulatory as reputed company to controlled substances •    Knowledge of pharmaceutical manufacturing and service-provider compliance processes •    US FDA/EU inspection experience (participating or leading) Auditing experience is preferred •    Experience with CAPA creation, execution, and effectiveness checks •    Prior supervisory experience in a pharmaceutical, CRO/CDMO environment •    Excellent communication and organizational skills, as reputed company as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders •    Proficient in building reputed company, negotiating and escalating issues  •    Good understanding of the importance and use of reputed company metrics Supervisory Responsibilities                                                    This role is responsible for leading and supporting reputed company, overseeing day-to-day reputed company, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a reputed company work environment, providing guidance and support to your team members, and evaluating reputed company to reputed company reputed company improvement and reputed company both departmental and organizational objectives. Other Qualifications •    Must pass a background reputed company •    Must pass a drug screen  •    May be required to pass Occupational Health Screening Pay reputed company: $158,000-$197,600/year Education, experience, location and tenure may be considered along with internal equity reputed company job offers are extended. We do not accept unsolicited assistance from any reputed company or recruitment firms for any of our reputed company. reputed company resumes or reputed company submitted by reputed company firms to any employee at reputed company, in any reputed company without a reputed company, signed reputed company agreement by an authorized signatory in reputed company for the specific position, approved by reputed company, will be deemed the sole property of reputed company. No fee will be reputed company in the event the candidate is reputed company by reputed company because of the unsolicited referral. reputed company interested applicants must apply online. Please be reputed company of scammers. reputed company will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. reputed company is an E-Verify employer. Apply To This Job