Sr. Manager, Quality Assurance QMS & Shared Services at CTMC

Houston, TX 77030, USA -

Full Time

Start Date

Immediate

Expiry Date

04 Dec, 25

Salary

0.0

Posted On

04 Sep, 25

Experience

12 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Training, Communication Skills, Ema, Validation, Sme, Management Skills, Operational Excellence, Iso, Manufacturing Processes, Customer Service Skills

Industry

Hospital/Health Care

Description

QUALIFICATIONS/SKILLS

Bachelor of Science in Engineering, Quality Management, Management, or related science discipline.
12+ yrs. related experience in manufacturing processes, QA, Operational Excellence and Training combined or equivalent combination of education and experience.
Understanding of Cell and Gene Therapies.
Comprehensive knowledge of validation lifecycle for aseptic processing, equipment/facility/utility validation.
Experience with Veeva QMS preferred.
Experience with Health Authority regulations (US FDA, EMA, ISO 9001, ISO 13485, etc.) preferred.
Demonstrate expertise in multiple QA related areas; SME in specific areas related to systems.
Understanding of cGxPs.
Knowledge of local and global regulations.
Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Strong analytical and problem-solving skills.
Proficient with Microsoft Office Suite or related software.

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Responsibilities

RESPONSIBILITIES

Manages and oversees the change control, deviation, CAPA and effectiveness check systems/programs.
Provides QMS leadership during eQMS development/improvement programs and/or projects involving department and cross-functional teams.
Provides KPI’s/KQI’s for all QMS programs.
Manages and oversees the Quality validation program (Installation and Operational Qualifications protocols and reports, discrepancies), calibration and maintenance records.
Assesses and approves change control proposals and implementations.
Evaluates and approve quality records.
Develops and delivers quality training to site.
Supports regulatory and clint audits as subject matter expert for validation and QMS.
Prepares and present periodic management updates on Department activities to Leadership.
Creates and manages the document control system (DCS), ensuring all documents are properly cataloged, indexed, and accessible
Identifies and reports document-related non-conformances and lead or support corrective and preventive actions (CAPAs).
Leads and participates in special projects related to quality systems and documentation.
Other duties as assigned.