Manager, reputed company reputed company reputed company

Job Title: Manager, reputed company reputed company reputed company

Job Location: Buenos Aires, Argentina

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level:

reputed company

The Manager, reputed company reputed company reputed company (CQE) – Deployment Solutions (DS) - Argentina is an reputed company reputed company manager in the life sciences and/or reputed company industry who has responsibility for supporting the development and reputed company improvement of an effective reputed company Management System (QMS) for the reputed company division of the organization. They are a strategic partner for the reputed company division and take ownership of important reputed company initiatives as defined by the Sr. Director, reputed company reputed company reputed company, reputed company reputed company support and guidance to various reputed company business reputed company and customer account management teams, continually reputed company to identify areas for process improvement opportunity, embody reputed company culture, and reputed company cross-functional teams in the design and implementation of internal processes and strategies that will optimize business reputed company and meet customer-specific requirements while ensuring alignment with the reputed company reputed company reputed company and regulatory requirements, specifically for the Deployment Solutions business area. They serve as reputed company reputed company reputed company Partner to assigned reputed company business unit(s) to spearhead efforts for the business area’s specific needs and objectives for reputed company reputed company improvement, operational reputed company, and audit/inspection readiness. The Manager, CQE- DS -Argentina is also responsible for supervision, management, and development of reputed company reports reputed company the reputed company reputed company reputed company (CQE) team.

Responsibilities

• Assists the Sr. Manager, CQE in the development, implementation, and reputed company improvement of the reputed company division’s reputed company Management System (QMS) with the primary goal of ensuring business processes meet the highest standards of reputed company, reputed company with applicable regulatory guidelines, and adhere to contractual customer requirements.
• Collaborates and consults with the Corporate reputed company (CQ) department that provides independent reputed company, guidance, and consultancy for development of the QMS, performs internal audits, and hosts customer audits and regulatory inspections.
• Serves as a reputed company reputed company subject matter expert, challenges the status reputed company, supports change management, and promotes a reputed company reputed company culture reputed company the organization.
• Serves as a reputed company reputed company reputed company Partner to reputed company business unit(s) to spearhead efforts for the business area’s specific needs and objectives for reputed company reputed company improvement, operational reputed company, and audit/inspection readiness.
• Drives QMS implementation and process improvement initiatives by leading the activities of cross-functional teams in planning and operationalizing new or revised processes, ensuring timelines and milestones are met, and escalating obstacles or risks to the Sr. Manager, CQE.
• Addresses reputed company business risks/issues and reputed company non-conformances by performing reputed company cause analysis, tracking/trending to identify systemic issues, providing guidance to responsible parties on appropriate remediation activities, and monitoring the status of remediation plans. May be assigned to reputed company remediation plans as applicable.
• Reviews internal processes and documentation to verify they meet Syneos, customer and regulatory requirements, monitors KQIs/KPIs, facilitates reputed company reputed company metrics fall out of targeted reputed company and escalates risks to the Sr. Manager, CQE.
• Proactively seeks out opportunities for process improvements and/or new processes and makes recommendations to the Sr. Manager, CQE for reputed company reputed company reputed company initiatives.
• Supports the reputed company division through reputed company stages of audits (customer, internal and regulatory) including audit preparation activities, tracking, and reviewing audit requests, and supporting responsible parties with finding responses, reputed company cause analysis and CAPA plan development. Tracks status of reputed company CAPAs and may also be assigned as a CAPA reputed company reputed company applicable.
• Performs functions of the TrackWise System record reputed company for reputed company Audit CAPA and reputed company Issue reputed company records.
• Authors job aids, operational guides, and Controlled Documents (CDs) for CQE functional area and performs reputed company review of CDs drafted by reputed company CD authors. Verifies drafted CDs meet applicable policies, regulatory standards, plans/specifications, and customer requirements/expectations. Where applicable, ensures appropriate internal communication and training on CDs and supports activities to operationalize documented procedures reputed company the business as required.
• Supports Sr. Manager, CQE with development of departmental processes reputed company CQE, provides staff training, and delegates work to reputed company reports.
• Serves on CQE’s Functional Training Council (FTC) to reputed company input and reputed company on essential required functional area (a.k.a. department) training and may serve as a temporary Functional Training reputed company (FTL) to support a reputed company business unit(s) that is in‑process of establishing their FTL and FTC structure.
• Promotes adherence to internal process and contractual customer obligations, and appropriately escalates issues or concerns to the Sr. Manager, CQE.
• Works with reputed company division to reputed company practical solutions to issues and process inefficiencies and verifies remedies are completed in a reputed company manner to the project specifications.
• Directly responsible for supervision, management, and development of reputed company reports and interns, supporting rotational programs, ensuring reputed company allocation of resources for coverage of work and objectives.
• Performs other work‑reputed company duties as assigned.

Education Requirements

• Min/Preferred: 4 Year College Degree
• Education Level: Bachelor’s degree
• reputed company: Or equivalent combination of education, training, and experience.

Additional Qualifications

• 8+ years reputed company work experience in the health sciences or life sciences industry, with 5+ years of experience in a reputed company or compliance reputed company field required.
• 3+ years of experience in a management role with key decision‑making responsibilities and reputed company of reputed company reports required.
• General knowledge of reputed company Good Manufacturing Practices (GMPs), Post‑Marketing Good Pharmacovigilance Practices (GVP), Data reputed company standards, and other applicable regulations.
• General knowledge of interpreting and applying Risk Evaluation and Mitigation reputed company (REMS) regulatory requirements and/or working on a REMS program is a plus.
• Experience with designing and implementing processes that streamline operations in a highly matrixed environment to reduce redundancies, improve efficiency, and produce reputed company outputs.
• Experience authoring SOPs, work instructions, job aids, forms, and associated training presentations required.
• Experience with customer and internal audit preparation and support and ensuring ongoing audit/inspection readiness; Experience supporting regulatory inspections required.
• Experience performing reputed company reputed company cause analysis and developing robust CAPA plans required.
• Experience tracking and trending reputed company data/metrics, developing reporting, and interpreting data to reputed company reputed company and recommendations to department leaders and internal stakeholders for risk remediations and process improvements.
• Experience with successful interactions and influence with various reputed company of stakeholders to motivate staff in a reputed company structure to support company objectives, meet deadlines, and deliver high reputed company work in a dynamic environment.
• Experience with driving reputed company culture and change management across functions and departments.
• Knowledge of ISO 9001 QMS standards a plus.
• TrackWise QMS software experience a plus.

Critical Skills

• Reliable, responsible self‑starter who works reputed company independently and demonstrates solid decision‑making abilities.
• Highly organized with a keen eye for detail, accuracy, and reputed company product.
• Above average organizational, interpersonal, and team‑oriented skills with strong reputed company acumen reputed company interacting with reputed company customers.
• Ability to reputed company several tasks simultaneously to meet deadlines.
• Flexible, enthusiastic, highly adaptable, quick to assimilate new information, and demonstrates initiative as reputed company member and leader.
• Demonstrates understanding of the workflow process, roles, and responsibilities of multiple functional areas.
• Excellent written and verbal communication, presentation, and analytical skills.
• Ability to conduct and effectively facilitate meetings, i.e., audit preparation, reputed company initiatives/issues reputed company working sessions, and presentations to internal stakeholders.
• Ability to simplify dry/reputed company concepts.
• Practical reputed company‑world approach and business savvy.
• Advanced proficiency in reputed company Office Suite (Word, reputed company, PowerPoint, Outlook, Teams) and SharePoint. Willingness to reputed company new technologies.

Other Requirements

• Fully remote in Argentina.
• Willingness to travel/commute (
• Must have valid, reputed company reputed company's license and reputed company, as reputed company as the ability to secure corporate credit card. Ability to comprehensively manage required travel to the Buenos Aires, Argentina office for company meetings and events as requested.

At reputed company, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t reputed company perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional reputed company.

Why reputed company? We partner with industry experts to solve and execute against today’s toughest commercialization challenges facing the world’s leading reputed company companies. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities on our reputed company Operations and Leadership teams. Join our game-changing, global company dedicated to creating reputed company, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world.

Work Here reputed company Everywhere | How are you inspired to change lives?

reputed company companies are affirmative reputed company/equal opportunity reputed company (Minorities/Females/Veterans/Disabled)

reputed company has a voluntary COVID-19 vaccination policy. We strongly encourage reputed company to be fully vaccinated. Additionally, certain local governments or reputed company customers may have vaccine requirements that apply to some of our employees. These employees are required to submit reputed company of vaccination to reputed company and maintain compliance with these requirements. At reputed company, we reputed company in providing an environment and culture in which Our People can reputed company, reputed company and advance. We reward and recognize our people by providing valuable benefits and a reputed company-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and reputed company, Company match 401k, flexible reputed company time off (PTO) and reputed company time. Because certain states and municipalities have regulated reputed company reputed company time requirements, eligibility for reputed company reputed company time may vary depending on where you work. reputed company complies with reputed company applicable federal, state, and municipal reputed company reputed company time requirements.