Pqm - Sterile & Cmo Platform

A fantastic opportunity has arisen for a Product Quality Manager. This role is accountable for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. The role has primary batch release duty and ensures that effective and robust Quality systems are in place to comply with regulations, policies, and guidelines governing the External Party manufacture and release by means of risk-based quality oversight and on-site supervision, as appropriate.

**Bring energy, knowledge, and innovation to carry out the following**:
Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records

**Responsibilities include but will not be limited to the following key activities**:

- Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
- Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented
- Oversee repackaging activities in the External Party Conduct routine analytical change requests and support process modification change controls
- Stability Program management, including review of stability reports, and Annual Product Review assembly
- Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements
- Track and monitor operational and quality performance of the external manufacturer/partner Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration, accountable for shipment under quarantine
- Promote routine process validation; review and approve validation reports/tech transfer Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes
- Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums

**Your profile**

In order to excel in this role, you will more than likely have a degree in science, engineering or any relevant technical discipline (BS biology, microbiology, pharmacy, chemistry, chemical engineering, or equivalent preferred).
- Previous experience in the pharmaceutical industry with some knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
- Problem solving & continuous improvement mindset
- Strong stakeholder management skills
- Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
- Answers to non-standard requests from clients and/or customers; investigations with assistance from others as needed
- Accountability for technical contribution to project team or sub-team; may manage/lead a small project team
- Ability to work across boundaries, developing interactive skills, relationship building and leadership skills
- Conveys easily in English both verbally and in writing
- Knowledge of External Manufacturing management, supply chain, and operations
- Lean Six Sigma Systems training is an advantage
- Ability to travel up to 10% of the time

As a company, we are dedicated to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

We are proud to be