- Primary responsibility for Quality systems in support of R&D activities, ANDA/NDA submissions and commercial operations including, but not limited to, Document Control, Change Control and Annual Product Review.
- Develop and maintain key Quality metrics for the functional area to serve as a tool for continued improvement.
- Supporting role and primary FDA interface for site inspections involving the above mentioned areas.
- Assure systems are in place and functioning to meet all regulatory requirements.
- Develop, maintain and mentor a staff of QA professionals.
- Bachelor's Degree in chemistry or related discipline required.
- 10+ years' pharmaceutical QA experience with quality systems,
- 2+ years' experience in a supervisory/management capacity in an oral solid dosage facility.
- Expert in cGMP's with a proven track record for providing reasonable cost effective solutions to issues identified.
- Strong understanding of FDA inspectional techniques, including experience with supporting and coordinating activities for inspections and the relational skills to develop and mentor a department as well as interacting with other professionals and management in the organization.
- Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing 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.
- Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
- Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed.
- Change Management - Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
- Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Strategic Thinking - Develops strategies to achieve organizational goals; understands organization's strengths & weaknesses; analyzes market and competition; identifies external threats and opportunities; adapts strategy to changing conditions.
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Manager, Quality Systems - Rochester, United States - Endo
Description
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.
The Manager, Quality Systems has primary responsibility for site Quality systems at a high-volume facility for commercial solid and liquid products. Working closely with key business partners in Manufacturing, Facilities, Operations, Regulatory Affairs, and Quality Control; this position will focus on the development of systems to assure compliance to cGMP's meeting FDA and company goals in an efficient manner.
Key Accountabilities
Quality Systems Management
65%
FDA Compliance
20%
Staff Development
15%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Skills & Abilities
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.
