Surmasis Pharmaceutical - Quality Manager; M - F

Surmasis Pharmaceutical - Quality Manager (M
- F)

We are seeking a highly motivated and experienced Quality Manager to lead our quality team in ensuring that all pharmaceutical products meet the highest standards of safety, efficacy, and quality. This individual will oversee the development, implementation, and continuous improvement of quality management systems, compliance with regulatory requirements, and coordination of internal audits. The ideal candidate will have a strong background in pharmaceutical manufacturing, quality control, and regulatory compliance.

PRIMARY DUTIES AND RESPONSIBILITIES

• Quality Management: Oversee and maintain the company’s Quality Management System (QMS), ensuring alignment with both internal and external standards, including FDA, EMA, ICH, and GMP.
• Regulatory Compliance: Ensure compliance with applicable pharmaceutical regulations (FDA, EMA, ICH, etc.) and work closely with regulatory agencies during audits, inspections, and submissions.
• Quality Control and Assurance: Lead efforts in the validation and verification of processes, procedures, and products to ensure adherence to specifications and GMP.
• Team Leadership: Supervise, mentor, and develop a team of quality assurance professionals, fostering a culture of quality and continuous improvement.
• Document Control: Manage and ensure the proper documentation of all quality processes, including SOPs, batch records, testing protocols, and deviation reports.
• Root Cause Analysis: Lead investigations into quality deviations, product complaints, and non-conformances, driving corrective and preventive actions (CAPAs) to prevent recurrence.
• Internal Audits: Plan, coordinate, and lead internal audits to assess the effectiveness of the QMS, identify areas for improvement, and ensure continuous compliance.
• Training and Development: Ensure that all employees are adequately trained in quality standards, procedures, and best practices.
• Supplier and Vendor Management: Evaluate and qualify suppliers, ensuring that materials meet quality standards and are compliant with GMP.

QUALIFICATIONS

Education:

Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related scientific/technical field. Advanced degree (MS, Ph.D.) preferred.

Experience:

Minimum of 6 years of experience in pharmaceutical quality, with at least 2 years in a managerial or supervisory role.

Certifications:

Relevant certifications (e.g., ASQ Certified Quality Manager, Six Sigma) are a plus.
Knowledge:
Deep understanding of GMP and FDA regulations pharmaceutical regulations.

Skills:

Strong leadership, analytical, and problem-solving skills. Excellent communication, organizational, and project management abilities.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, sit, and operate a computer. Specific vision abilities required by this job include close vision and distance vision.

WORK ENVIRONMENT

Office environment with business casual dress. May require business attire.

• Full Benefits:
  Medical, Dental, Vision, Short-Term Disability (STD), Long-Term Disability (LTD), and Life Insurance options
• 401(k) Retirement Plan
• Paid Time Off (PTO) awarded immediately
• 7 paid holidays per year, including New Year’s Day, Memorial Day, 4th of July, Labor Day, Thanksgiving (Thursday & Friday), and Christmas Day