Sr Manager Quality Systems Jobs

Train internal/external staff on quality management system requirements.

Project and team management skills

Experience with quality management system development – required

Ensures that the quality management system demonstrates regulatory compliance per QSR, ISO, and other applicable regulations.

Prepare management representative meeting data/presentation and may be assigned management representative for assigned facility.

Trend Quality data. Monitor trends and create reports for management review.

• Exceptional working knowledge/experience administering server operating systems (Windows & Linux).

• Familiarity with cloud concepts such as containerization (Docker, Kubernetes) and cloud management platforms.

• Strong written communication skills, including experience documenting standard operating procedures and writing technical documentation (runbooks).

Remote work flexibility after a desired length of tenure and good performance

• Experience supporting cloud-native SaaS applications such as Office 365 and Salesforce.

• Strong skills in TCP/IP networking and security concepts are required.

Proven experience as a Program Manager or in a similar project management role within a creative agency, product, or design department

Strong leadership and team management skills, with the ability to motivate and inspire creative teams

Proficient in project management tools and software to streamline workflows and track project progress

Lead and manage the end-to-end execution of projects, ensuring adherence to timelines, budgets, and quality standards

Foster a collaborative and positive team environment, promoting effective communication and knowledge sharing

Demonstrated ability to successfully manage multiple projects simultaneously, prioritizing tasks effectively and meeting deadlines

Train Quality and Production personnel in Quality requirements relating to specific programs

Completion and documentation of all phases of the Advanced Product Quality Planning (APQP) process

Prepare and submit all necessary PPAP documentation per AIAG guidelines

Develop gauge concepts and procure gauges for specific programs

Participate in Simultaneous Development Teams (SDT’s)

Participate in internal audits as required

EO Change Management (Review and approve PPAP, Follow up with related department's requirements)

Ensure proactive management by the Quality Team and validation of the following collected by the Quality Team

Work closely with Supplier Quality Manager and other Dept. to support plant requirements

Knowledge of production processes, quality requirements and other techniques for maximizing the effective manufacture of products.

Knowledge and lead IATF quality system requirements

In-depth knowledge of PPAP/PFMEA/Control Plan documentation

Previous experience working with Document Control Systems and Quality Management Systems, Regulations, and Standards

Strong organizational and project management skills, with attention to detail and accuracy

Medical Benefits – We offer a range of policies through TriNet

We are looking for an experienced Quality Systems Manager to join our team.

Perform other ISO 13485 and 21 CFR 820 related activities as assigned by reporting manager.

Perform any other related activities assigned by reporting manager.

Support Risk Management activities for the HHE, Complaint and CAPA process.

Conduct risk management/risk assessment activities.

Support the Quality Management System (e.g., facilitate change orders, CAPAs, Document Control, and Design Control System).

Perform equipment, product, and process qualifications/validations.

Manage and conduct both internal and external audits and qualify new suppliers and/or components.

Works with the Calibration department on development of gauging, review and approve calibrations to requirements and conduct Out of Tolerance investigations.

In depth quality assurance and experience in solutions, projects, and services

Excellent interpersonal and customer relationship skills to address quality issues

Ability to manage multiple and conflicting priorities

Work on cross functional teams

Solid understanding of Quality improvement principles, RCCA, and Six Sigma

Ability to lead, drive change, and influence others

Approval of change management activities.

Participate as requires in Audits and Management Reviews

Lead/ participate in quality systems and compliance improvements that results from all Audits, management Reviews and any other NCR/CAPA system indicators.

Knowledge of 21 CFR 820, ISO 13485, ISO 14971 and EU MDR, and CE regulatory requirements

Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.

Minimum 5+ years work experience in quality, manufacturing, or engineering.

5 years management/supervisory experience in cGMP organization.

Experience working with CMOs, CTLs, vendors, and relationship management preferred

Working knowledge of relevant US and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections.

Bachelor’s degree in relevant scientific discipline with minimum experience of 10 years within quality control.

Experienced in executing quality control testing, analytical method transfers and validation within a biotechnology industry.

Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.

Develop and implement QA GLP/GCLP/GCP systems, risk management processes, and SOPs for internal and external oversight operations

Must have proficient computer skills and be experienced using MS office software (Word, Excel, PowerPoint, Project)

Previous direct QA experience in GLP/GCLP/GCP in pharma required

Prior experience with nonclinical studies and CRO oversight

Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately

Manager/ Sr. Manager of Quality Assurance GCP/GCLP/GLP

A project leader, with strong project management skills and able to balance competing priorities

Prior experience leading large and complex global projects, to include system implementations

Experienced at managing external service providers against established contractual obligations

An expert with legal and regulatory requirements governing HR as well as data privacy, including GDPR

Deploy new solutions and manage continuous improvement with a strong focus on efficiency, data privacy, and compliance

Communicate effectively and manage Workday project stakeholders across multiple levels of the organization

Proactively manages quality assurance and compliance activities in order to produce the highest quality products and prevent defects.

Develops and deploys Quality and Compliance strategies that are aligned with Medtronic’s strategy across areas of responsibility.

Creates a world class Quality organization ensuring top talent is hired, developed, and retained.

A Day in the Life

· Must have a working knowledge of all applicable regulatory requirements

· Previous experience in performing the duties and responsibilities defined within job description

· Must have at least 5 years working experience in Flight Operations

· Must have at least 5 years previous supervisory experience

· Effective written and verbal communication skills

· Responsible for planning and implementing IROP (irregular operations) initiatives such as major cancellations or delays.

Background in Medical Device industry is highly desired.Pharmaceutical experience only would be acceptable.

Technical Writing (author SOPs & Work Instructions)

Medical Device (pharmaceutical is fine)

This person will assume a hands-on role and report into the IT Business Partner.

This Candidate must have a background in the following:

4) Preference will be given to candidates with recent experience in quality management

6) Serve as a strategic leader to direct, oversee and manage all activities in the Quality Department

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biopharmaceutical industry is strongly preferred

1) Oversee the Quality Control, Quality Assurance and Analytical Development teams

3) Develop and direct site quality systems and procedures

Partner with Ops / ERP system management team to ensure lot traceability capability

MANAGER: Quality Management System Director

Ensure systems maintain compliance with internal/ external requirements through data-driven oversight

Analyze underlying system issues and identify/define alternatives, assess feasibility and manage implementation of recommended solution

7 - 9 years System/IT/Configuration and administrative support experience in an FDA regulatory industry preferably in a Quality and Operations function

Strong organizational and communication skills with the ability to clearly explain and visualize processes and workflows.

Responsible for quality event management (deviations, investigations, change control) related to method qualification / validation.

Provide technical and strategic functional oversight, including resource management/operational management for method validation, transfer and testing of Raw Materials.

Manage outsourced qualification / validation and GMP testing of methods at CMOs or CTLs.

Extensive technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOPs.

Review and approve method qualification / validation protocols and reports, may need to author method qualification / validation protocols and reports.

Collaborate with Analytical Development Scientists, Formulation, Process Development, Conjugation to gain the necessary method and product knowledge.

5+ years’ experience in a quality and/or compliance management role.

Strong collaborator, internally and externally, with exceptional time management and organizational skills.

Facilitate periodic Quality Management Review.

Expertise in compliance with respect to Quality Systems, Quality Compliance and Quality Risk management.

Manage and provide vision and leadership for the Quality organization at all ADL manufacturing sites.

Manage site supplier quality process.

6+ years of experience leading a curation QC or Data Quality team with experience in the project management discipline.

6+ Information Governance, Data Management, DQ Experience.

Data curation control staff (global) team management; capacity planning; profile specifications.

Lead data cuts certification process design/ implementation/oversee.

Define requirements for a QC monitoring dashboard.

Develop QC standards in accordance with industry best practices and compliance /regulation requirements.