- 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.
- Stand, walk, sit.
-
Lead, Quality Systems
4 days ago
GXO Logistics Sterling, United States**Logistics at full potential.** · At GXO, we're constantly looking for talented individuals at all levels who can deliver the caliber of service our company requires. You know that a positive work environment creates happy employees, which boosts productivity and dedication. On ...
-
Manager, Quality Systems
2 weeks ago
Endo Rochester, United StatesWhy 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 ...
-
Manager, Quality Systems
1 week ago
Endo Rochester, United StatesWhy 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 dedicate ...
-
Quality Systems Engineer
2 weeks ago
Dana Incorporated Auburn Hills, United StatesJob Duties and Responsibilities · Implement quality systems with special emphasis on maintaining TS16949 & ISO 14001 certifications. Monitor and maintain QS/TS/Quality Operating System requirements · Coordinate supplier quality management metrics including but not limited to prev ...
-
Quality Systems Engineer
2 weeks ago
Dana Incorporated Auburn Hills, United StatesJob Duties and ResponsibilitiesImplement quality systems with special emphasis on maintaining TS16949 & ISO 14001 certifications. Monitor and maintain QS/TS/Quality Operating System requirements · Coordinate supplier quality management metrics including but not limited to prevent ...
-
Quality Systems Coordinator
3 weeks ago
Inalfa Roof Systems Group B.V. Auburn Hills, United StatesWe open up your world with every drive · Would you like to work on the development of roof systems for future car models together with some of the market leaders in the automotive industry? Inalfa Roof Systems is a world leading supplier for OEM automotive roof systems and still ...
-
Quality System Specialist
3 weeks ago
Sodecia Troy, United StatesJob Description Job DescriptionPrimary Purpose of PositionReporting to the Quality VP, you will be responsible for review and update the quality system manual in accordance to the latest version of required quality norms, assure the quality system implementation in the Sub-Holdin ...
-
Quality System Specialist
4 weeks ago
Sodecia Troy, United StatesJob Description · Job Description · Primary Purpose of Position · Reporting to the Quality VP, you will be responsible for review and update the quality system manual in accordance to the latest version of required quality norms, assure the quality system implementation in the ...
-
Quality System Specialist
2 weeks ago
Sodecia Troy, United StatesJob Description · Job Description Primary Purpose of Position · Reporting to the Quality VP, you will be responsible for review and update the quality system manual in accordance to the latest version of required quality norms, assure the quality system implementation in the Sub- ...
-
Quality Systems Engineer
2 weeks ago
The Bartech Group Inc Sterling Heights, MI, United StatesIf you are an experienced Quality Engineer looking for a position with a leading company, Bartech can help Our client has a need for a Quality Engineer. This is a contract position; however it is not uncommon for assignments to transition into permanent positions with our client ...
-
Quality Systems Manager
2 weeks ago
PCA Plymouth, United StatesAs a Fortune 500 company, Packaging Corporation of America (PCA) is an ideas and solutions company. Our corrugated packaging business seeks to be the leader in helping our customers — large and small — package, transport and display products of all kinds. Our white paper business ...
-
Quality Systems Lead
1 week ago
LM Manufacturing Detroit, United StatesJob Description · Job DescriptionPosition Summary: To lead implementation of TS16949, Ford specific TS, Q1, MSA, GPDS and CQI requirements and to deploy an effective internal auditing system focused to measure and improve process effectiveness. · Responsibilities: · Develop, imp ...
-
Quality Systems Lead
6 days ago
LM Manufacturing Detroit, United StatesPosition Summary: · To lead implementation of TS16949, Ford specific TS, Q1, MSA, GPDS and CQI requirements and to deploy an effective internal auditing system focused to measure and improve process effectiveness. · Responsibilities: · Develop, improve, implement and maintain pr ...
-
Quality Systems Manager
3 weeks ago
Packaging Corporation of America Plymouth, United StatesQuality Systems Manager - Plymouth, MI · Plymouth, MI 48170, USA · Req #19938 · Thursday, May 2, 2024 · As a Fortune 500 company, Packaging Corporation of America (PCA) is an ideas and solutions company. · Our corrugated packaging business seeks to be the leader in helping ou ...
-
Quality Systems Engineer
3 weeks ago
QMC-EMI Holdings Corporation Livonia, MI, United StatesFor 60 years, Quality Metalcraft (QMC) and Experi-Metal Inc (EMI) have been leaders in innovative structural solutions for the mobility industry. Joining forces, QMC-EMI makes the production and prototype parts that could be used in the next airplane you take or the next car you ...
-
beBee Handyman Brady, TX, United States FreelanceWe are looking for someone in Brady, TX to advise us on the installation of a ducted air conditioning system.Type of job to be done · Installation · Type of air conditioning · Ducted · Is pre-installation of ducts necessary? · Yes · Brand of air conditioning · Mitsubishi · When d ...
-
beBee Handyman West, TX, United States FreelanceI am in need of a Computer Repair service in West, TX with the following characteristics:What is wrong with your computer or device? · It does not turn on · What type of device is it? · Laptop · Operating system of the device · Asus · Is the device under warranty? · No · Where wi ...
-
beBee Handyman Melvin, TX, United States FreelanceI am in need of a service to install a salt chlorinator in Melvin, TX with the following characteristics:Pool usage type · Private (personal) · Approximate pool area · Less than 15 m2 · Is the pool in-ground or above-ground? · In-ground (buried) · Pool type (indoor or outdoor) · ...
-
beBee Handyman Lorena, TX, United States FreelanceLooking for a tutor in Lorena, TX who is proficient in A3 ERP system and accounting. Class type: Individual classes · Subjects needed: Taxation, financial accounting · Student level: Adult education · Approximate hours per week: 1 hour · Preferred locations for classes: At home, ...
-
Quality Systems Engineer
3 weeks ago
Capgemini Detroit, MI, United States Full timeCapgemini supports all aspects of your well-being throughout the changing stages of your life and career. Flexible work · Healthcare including dental, vision, mental health, and well-being programs · Financial well-being programs such as 401(k) and Employee Share Ownership Plan ...
Manager, Quality Systems - Rochester, United States - Endo International
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.
Job Description Summary
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.
Job Description
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Supports the Quality Systems function for the Irvine, CA location. Manages up to three employees.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Quality Systems Management
FDA Compliance
Staff Development
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Abilities
Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
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.
