Head of Quality Control

```html

About the Company

The company is Pennsylvania Corporation with headquarters in Harrisburg. We offer latest technology high quality sterilizing membrane filters which are manufactured in state-of-the-art, certified ISO-7 clean facility. The facility is also ISO 9001:2015 certified and follows Good Manufacturing Practices. The products are used for purification and separation applications in a wide range of industries such as Pharmaceutical, Biopharmaceutical, Biotechnology, Hospitals and Immunodiagnostics. The business is divided into three segments, namely:

• Products for Microfiltration
• Products for Rapid Immunodiagnostics
• Technical Services

About the Role

We are seeking a highly experienced and assertive professional to lead the Product Quality function across our biotech/pharmatech operations. The role demands a mature leader (10–15 years of experience) with strong technical expertise, strategic vision, and the ability to drive quality initiatives across functions. The incumbent will ensure that all products meet the highest standards of safety, efficacy, and global regulatory compliance.

Responsibilities

• Lead and oversee end-to-end Quality Management Systems (QMS) ensuring compliance with ISO and other global regulatory standards.
• Drive Quality Assurance, Quality Control, Product Testing, and Release processes for biotech/pharmatech products.
• Foster a culture of quality and continuous improvement across manufacturing, R&D, and supply chain functions.
• Build and mentor a high-performing quality team with accountability and discipline.
• Collaborate with senior leadership across Production, R&D, Supply Chain, and Regulatory Affairs.
• Ensure proactive risk identification, root cause analysis, and CAPA implementation.
• Develop and track quality metrics and dashboards for leadership review.
• Take assertive action to uphold product integrity and patient safety.

Qualifications

• Experience: 10–15 years in biotech/pharma tech quality management, with at least 5 years in a senior leadership role.
• Education: B.Pharm / M.Pharm / M.Sc (Biotech, Microbiology, Life Sciences) / Ph.D.

Required Skills

• Proven track record in audits (ISO, regulatory) and compliance management.
• Strong leadership presence – mature, assertive, and results-driven.
• In-depth knowledge of quality frameworks and global standards.
• Strategic mindset with hands-on problem-solving approach.

Preferred Skills

• Assertive decision-making and leadership.
• Strong regulatory and compliance acumen.
• High integrity and commitment to product quality.
• Effective communication and cross-functional collaboration.
• Ability to push for results while maintaining team alignment.

Pay range and compensation package

Salary: As per company norms (no bar for deserving candidates)

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.

```