Manager, External QA

Job Description

EXTERNAL QUALITY ASSURANCE -Senior Specialist Qualified Person (QP) China

The Position

The Product Quality Manager (PQM) Senior Specialist is 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.

Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP’s manufacture and release of (non-sterile pharmaceuticals, sterile pharmaceuticals, medical devices) by means of risk-based quality oversight and on-site supervision, as appropriate.

PQM 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, manufacturing process complexity.

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

• Conduct audits of EP/ExP 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 in the ExP/EP

• Conduct routine and solves 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 can 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

Required Education, Experience and Skills:

• Degree in Pharmacy, Chemistry, or Chemical Engineering or equivalent

• Minimum 5 years previous experience in multinational pharmaceutical industry in laboratory testing and in-process quality control.  Thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred.

• Solves complex problems; takes a new perspective using existing solutions

• Works independently, receives minimal guidance

• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME

• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others

• Explains difficult issues and works to build alignment around a complex situation

• Accountable for a medium project with minimal resource requirements, risk and/or complexity

• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills

• Excellent communication skills in both English and Chinese.

• Strong knowledge of External Manufacturing management, supply chain, and operations

 

Travel:

• Ability to travel up to 25% of the time

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1