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Manager, Quality Operations

4 months ago

Rochester, United States Endo International Full time

Why Endo?We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.Job Description SummaryThe Manager, Quality Operations directs the activities of the QA Operational staff to ensure Par Quality Operations remain in compliance with all supporting systems as per regulations. Also develops/revises procedures for the dept. Also monitors compliance and business needs with appropriate departments to ensure operational objectives are met.Job DescriptionScope of AuthorityQuality operations management primarily within a single site.Key Accountabilities -Quality Operations ManagementMonitor packaging, manufacturing, R&D, and raw material sampling system processes to improve QA function.Provide expertise to resolve floor issues; implement corrections; ensure deviations opened.Review/approve master batch records, packaging records in support of operations.Raw material/Packaging Component/Bulk Drug Product Release.Author/review QA Operations SOPs and protocols.QA Review of environmental monitoring alarms.Monitor and trend batch record errors and provides Senior QA Management with quality indicator data derived from supporting systems such as CME.Coordinate interdepartmental activities with QC, Supply Chain and Operations to meet business requirements.Responsible for quarantining/rejecting product due to investigations disposition, field alerts, recalls etc.Oversee movement of controlled substance within facility; including transport of product from receiving, production, packaging, QC or R&D to/from secured location.Support investigative process; write report if QA responsible for deviation or trend.50%ComplianceResponsible for the quality monitoring manufacturing and packaging processes to assure cGMP compliance and adherence to company SOP's.Assist internal quality initiatives and internal audits; assist with FDA inspections.Respond to audit observations and implement CAPA for Quality Operations.20%Continuous ImprovementWork with Quality mgt to address issues and identify trends to ensure compliance; foster development/implementation of process improvement within organization.15%Staff DevelopmentSelect, develop, evaluate personnel to ensure efficient operation of QA function.Ensure staff is trained in GMPs/the appropriate SOPs and is up to date.Provide guidance, training, coaching and work assignments for QA operational staff.15%Total100%QualificationsEducation & ExperienceBachelor's degree in related scientific discipline required. Advanced degree a plus.10+ years' related experience in a pharmaceutical or related Quality Assurance environment.3+ years' supervisory experience.Demonstrated management/supervisory experience with strong interpersonal and influencing skills.KnowledgeStrong knowledge of Quality concepts and practices.Understanding of cGMP principles, solid dosage manufacturing, OSHEA and DEA regulationsSolid understanding and use of ANSI sampling techniques and principles.Solid understanding and use of basic lab testing equipment and gauges such as balances, thickness gauges and sampling thieves.Intermediate principles of mathematical and statistical computations.Skills & AbilitiesJudgment - Willingness to make decisions; exhibit sound, accurate judgment; support/explain reasoning for decisions; include appropriate people in decision-making; makes timely decisions.Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; takes calculated risks to accomplish goals.Delegation - Delegate work assignments; match responsibility to person; gives authority to work independently; sets expectations; monitors delegated activities; provides recognition for results.Planning/Organizing - Prioritize/plan work activities; use time efficiently; plan for additional resources; set goals/objectives; organize/schedule people and tasks; develop realistic action plans.Managing People - Includes staff in planning, decision-making, facilitating, process improvement; takes responsibility for subordinates' activities; is available to staff; provides regular feedback; develops subordinates' skills, encourages growth; solicits/applies customer feedback (int/ext); fosters quality focus in others; improves processes, products, services; continually works to improve supervisory skills.Problem Solving - Identifies/resolves problems timely; gathers/analyzes info skillfully; develops alternatives; works well in group problem solving; uses reason even with emotional topics.Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.Initiative - Volunteers readily; undertakes self-development; seeks increased responsibilities; takes independent actions and calculated risks; takes advantage of opportunities; asks for and offers help when needed.Excellent written and oral communication skills with strong emphasis on organizational capabilities and external communications.Demonstrated flexibility in carrying out various assignments in a high-quality work environment.Strong attention to detail.Physical RequirementsThe noise level in the work environment is moderate.The work environment is a combination of manufacturing floor and office settings.The position requires bending, sitting, standing and minimal lifting.Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.Commitment to Diversity, Equity, and Inclusion: At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.EEO Statement:At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.