Quality Control Manager

Organization Overview

MPI is an FDA-reviewed manufacturer of NDA and ANDA products, operating as:

• A sterile fill/finish pharmaceutical manufacturer

• A CMO/CDMO partner

• A registered 503B outsourcing facility

MPI operates two facilities totaling approximately 100,000 square feet of manufacturing space and continues to expand sterile production capacity.

MPI is part of the McGuff family of companies, a privately held, veteran-owned organization founded in 1972 with a long-standing reputation for regulatory integrity and operational discipline.

Role Summary

The Quality Control Manager provides strategic and operational leadership over all QC functions, including:

• Production quality monitoring

• Incoming materials oversight and disposition

• Analytical chemistry laboratory operations

• Microbiology laboratory operations

• Enterprise document control administration (MasterControl or equivalent)

This leader will ensure inspection readiness, regulatory compliance, scientific rigor, and robust data integrity governance across the organization.

The role offers direct executive access and meaningful influence over quality systems architecture, personnel development, and operational scalability.

Scope of Authority

The QC Manager will:

• Lead and develop multidisciplinary QC teams

• Oversee incoming material receipt, quarantine, sampling coordination, testing, and release

• Direct analytical and microbiological testing in support of batch release

• Review and approve laboratory investigations (OOS, OOT, deviations, CAPA, change controls)

• Administer and optimize the enterprise EDMS (MasterControl preferred)

• Ensure compliance with 21 CFR Parts 210, 211, and 11

• Maintain full ALCOA data integrity compliance

• Serve as QC SME during FDA inspections and client audits

• Drive process improvement initiatives aligned with growth objectives

This is not a maintenance role — it is a leadership position intended to strengthen systems, elevate performance standards, and support continued sterile manufacturing expansion.

Ideal Candidate Profile

We are seeking a quality leader currently operating within a mid-to-large pharmaceutical organization who is motivated to assume broader ownership and decision-making authority.

Required Qualifications

• Bachelor’s degree in chemistry, microbiology, pharmacy, or related discipline (advanced degree preferred)

• 7 years of progressive experience in sterile drug manufacturing within FDA-regulated cGMP environments

• Demonstrated leadership over analytical chemistry and/or microbiology laboratories

• Direct experience with enterprise EDMS platforms (MasterControl strongly preferred)

• Strong working knowledge of 21 CFR Parts 210, 211, and 11

• Proven track record supporting FDA inspections

• Established expertise in data integrity and ALCOA principles

Highly Valued Experience

• Sterile fill/finish or aseptic processing environments

• 503B outsourcing operations

• CMO/CDMO or client-facing manufacturing

• LIMS integration with EDMS platforms

Compensation & Benefits

MPI offers a competitive compensation package commensurate with experience and leadership scope, including:

• Competitive base salary (structured for senior-level talent)

• Performance-based incentive opportunity

• Comprehensive medical, dental, and vision coverage

• 401(k) with company contribution

• Paid time off and company holidays

Compensation will align with the candidate’s regulatory experience, inspection history, and leadership background.

Why This Role Appeals to Leaders from Larger Organizations

• Greater operational autonomy

• Direct executive visibility

• Broader systems ownership (materials, labs, document control)

• Meaningful impact on inspection readiness and quality infrastructure

• Growth trajectory within an expanding sterile manufacturing operation

This opportunity is well-suited for a quality professional seeking to transition from a highly matrixed corporate structure into a leadership role with tangible influence and accountability.

Application Process

Candidates may submit resumes and inquiries to: employment.MPI@mcguff.com