Quality Control In Jobs in Bells, TN (NOW HIRING)

Position Summary

The Senior Manager, Quality Control is responsible for leading all QC laboratory operations and ensuring that pharmaceutical products meet applicable regulatory, quality, and safety standards. This role provides strategic and operational oversight of analytical testing, method lifecycle management, data integrity, and batch disposition support in a cGMP environment.

The position plays a critical role in ensuring compliance with 21 CFR Parts 210/211, global regulatory expectations, and internal quality systems while driving continuous improvement and inspection readiness.

Senior QC leadership is expected to proactively identify risks, ensure timely product release, and build a high-performing, compliant organization.

Key Responsibilities

Quality Control Operations:

· Lead daily QC laboratory operations including raw material, in-process, and finished product testing

· Ensure accurate, timely, and compliant generation of analytical data to support batch release

· Oversee scheduling, prioritization, and execution of testing activities aligned with production needs

Regulatory & GMP Compliance

· Ensure all QC activities comply with cGMP, FDA, and ICH guidelines

· Serve as SME during regulatory inspections and internal audits

· Maintain inspection readiness and lead responses to regulatory observations

· Ensure adherence to data integrity principles (ALCOA+) and laboratory controls

Method Lifecycle & Technical Oversight

· Oversee analytical method development, validation, transfer, and verification

· Ensure suitability of test methods and equipment for intended use

· Provide technical leadership for complex investigations and OOS/OOT events

Laboratory Leadership & People Management

· Lead, mentor, and develop QC staff including analysts, supervisors, and leads

· Establish performance expectations, training programs, and competency assessments

· Build a culture of accountability, compliance, and continuous improvement

Batch Release & Quality Systems

Review and approve:

· Analytical data packages

· Certificates of Analysis (COA) / Certification of Irradiation (COI)

· Stability data and trending reports

· Support disposition decisions in collaboration with QA and Manufacturing

Ensure proper execution of:

· Deviations / Investigations

· CAPA

· Change Control

Stability & Environmental Monitoring

· Oversee stability programs including protocol design, data review, and reporting

· Ensure trending and evaluation of environmental monitoring (EM) data where applicable

Continuous Improvement & Metrics

· Establish and monitor QC KPIs (e.g., right-first-time, OOS rate, turnaround time)

· Drive process improvements using Lean/Six Sigma principles

· Implement digital tools and data analytics to enhance laboratory performance

Cross-Functional Collaboration

· Partner with Manufacturing, QA, Regulatory, and Supply Chain

· Support product development, tech transfer, and lifecycle management activities

· Collaborate with external labs, CMOs, and vendors as required

Qualifications

Education

· Bachelor’s or Master’s degree in Chemistry, Microbiology, Biochemistry, or related scientific discipline

Experience

· 5+ years of pharmaceutical QC experience

· 3–5+ years in leadership/management roles

· Experience in sterile products required

· Experience with MasterControl e-QMS preferred

Technical Expertise

Strong knowledge of:

· cGMP (21 CFR 210/211)

· Analytical techniques (HPLC, GC, UV, microbiology, etc.)

· Stability programs and method validation

· Experience with laboratory investigations (OOS, deviations) and root cause analysis

Leadership & Systems

· Experience implementing or managing Quality Management Systems (QMS)

· Strong understanding of data integrity and electronic systems

· Proven ability to lead teams and drive organizational performance

Preferred Qualifications

· Experience in a 503B outsourcing facility or CDMO environment

· Prior involvement in regulatory inspections (FDA, EMA, etc.)

· Experience with electronic QMS platforms (e.g., MasterControl)

· Certification (ASQ CQE, Six Sigma, etc.) preferred

Key Competencies

· Strategic leadership and decision-making

· Strong problem-solving and root cause analysis

· Effective communication across all organizational levels

· High level of accountability and ownership

· Ability to operate in a fast-paced, growth-oriented environment

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance
• 
  
• Required

Education:

• Master's (Preferred)

Experience:

• pharmaceutical QC : 6 years (Required)
• sterile products: 5 years (Required)
• MasterControl e-QMS: 3 years (Preferred)
• 503B outsourcing facility or CDMO environment: 3 years (Required)