Senior Product Quality Manager
Il y a 7 mois
**Senior Product Quality Manager - External Quality Assurance (QP)**
To be preferentially based in Cramlington (UK), Amsterdam or Oss (The Netherlands), or Heist op den Berg (Belgium).
**Welcome to the team**
The External Quality Packaging department consists of 25 people in charge of the oversight of the packaging sites around the world that act as CMOs to Organon. We are a very Dynamic and Diverse team working virtually from all around the world.
**Purpose of the role**
Reporting into the External Quality Assurance Associate Director as a Senior Product Quality Manager (PQM) you will be responsible for ensuring that all company 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. You will need to ensure that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines, governing the external partners’ manufacture and release of (non-sterile pharmaceuticals, sterile pharmaceuticals and medical devices) by means of risk-based quality oversight and on-site supervision, as appropriate.
You will support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between our company and the partner and/or manufacturing process complexity.
**Main responsibilities**
- 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 of our company and compliance with all governing regulations; review and approve changes to master batch records.
- Manage routine and complex 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 partners by the Company and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.
- Oversee repackaging activities with the external partners.
- Conduct routine and solve complex 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 and work with supplier to develop CAPA plans.
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine.
- Support 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**
- Bachelor’s or master’s degree in pharmacy, Chemistry, or Chemical Engineering or equivalent;
- At least five years of previous experience in the pharmaceutical industry.
- Knowledge of Quality Systems, Quality Assurance and Quality Control including global GMP Quality Systems and regulatory requirements.
- Eligible to act as Qualified Person within the meaning of Article 48 of Directive 2001/83/EC.
- Experience in non-sterile oral dose and medical device pharmaceuticals preferred.
- Able to solve complex problems; able to take a new perspective using existing solutions.
- Able to work independently under mínimal guidance.
- Able to act as a team or project lead and lead work of others as required.
- Able to promote teamwork and open discussion of issues, coaches, and guides others.
- Able to explain difficult issues and work to build alignment around complex situations.
- Accountable for a medium project with mínimal resource requirements, risk and/ or complexity.
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
- Strong knowledge of External Manufacturing management, supply chain, and operations.
- Excellent communication skills in English.
- Ability to travel internationally to a maximum of 10% of the time.
**Secondary Job Description**
**Who We Are**:
Organon delivers ingenious health solutions that
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