QA Operations Manager, PCU Lead

Description

This is a new vacant role in Manufacturing & Supply, open for applications now.

The company is an R&D-driven, AI-powered biopharma firm that invents medicines and vaccines for millions of people.

In this role you help bring treatments to people everywhere, sooner, by changing how manufacturing and supply work.

You would join a supportive team that looks ahead.

Responsibilities

• Set annual quality assurance goals for E&M/Distribution manufacturing that match the company's strategy and direction.
• Make sure all E&M/Distribution production meets GMP, regulatory rules and company quality standards.
• Run a system that finds, tracks and reduces quality risks in E&M/Distribution manufacturing.
• Own batch release, including releasing batches for further processing and making sure finished batches are dispositioned on time and in line with compliance rules.
• Lead investigations into quality problems, deviations and out-of-specification results in E&M/Distribution.
• Oversee every E&M/Distribution production investigation, covering risk assessment and product impact.
• Work closely with production teams to keep quality high across E&M/Distribution.
• Run regular audits of E&M/Distribution processes and address the potential quality issues they reveal.
• Resolve E&M/Distribution quality issues promptly and effectively.
• Define and track KPIs for E&M/Distribution quality assurance work.
• Drive continuous improvement that raises quality and operational efficiency in production.
• Build a culture of quality across the E&M/Distribution organization.
• Assess new technologies, tools and methods, and recommend those that strengthen E&M/Distribution quality assurance.
• Lead and manage the E&M/Distribution quality assurance team, including hiring, training, coaching and performance reviews.
• Make sure the team is qualified and trained on current GMP requirements and quality standards.
• Take part in regulatory inspections and audits, acting as the quality expert for E&M/Distribution.
• Keep the site's manufacturing licenses and product permissions valid for E&M/Distribution.
• Support other duties as required.

Requirements

• A minimum bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, engineering or a related field.
• An advanced degree is preferred.
• At least 8 years of experience in quality roles.
• Pharmaceutical industry experience is preferred.
• In-depth knowledge of GMP regulations and guidelines is preferred.
• Previous management experience is preferred.
• A solid understanding of pharmaceutical manufacturing processes and the quality control methods used with them.
• Strong analytical and problem-solving skills, with the ability to make decisions based on data.
• Proven experience leading and coaching teams, and helping people and ideas grow.
• Clear communication and good interpersonal skills.
• Ability to work effectively with stakeholders across cross-functional teams and manufacturing operations.

Conditions

This is an onsite role.

Open to applicants in North America only.

The salary range is 102,600.00 - 152,600.00, including target bonus.

Final pay depends on demonstrated experience, skills, location and other relevant factors.

The company does not discriminate in hiring on the basis of race, ancestry, sex, age, citizenship, gender identity or any other protected characteristic.

Benefits

• A rewards package that recognizes your contribution.
• Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
• Career growth through promotions, lateral moves, and roles at home or internationally.
• Eligibility to take part in company employee benefit programs, with more details available from the company.