Assoc. Dir, External Quality

1 month ago

Shanghai, China Organon Full time

Job Description

Position Overview - Basic Functions & Responsibility

Essential function(s) includes, but is not limited to:

The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.

The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g. small molecules, biologics, sterile product, excipients, active pharmaceutical ingredients, intermediates, through direct oversight, support and technical advice, counseling to site leadership, and on-site supervision. The Associate Director may serve as a subject matter expert for External Quality and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).

The Quality Lead role should be based (Shanghai, China) where the company is located, and should be able to effectively interact and be the primary quality contact with local Health Agency during routine communication/reporting and Health Agengy inspections to the Market Authorization Holder (MAH) entity or even Contract Manufacture Operations (CMO) site. 

Primary Activities

Primary activities include, but are not limited to:

  • May manage a team of Quality Assurance professions as direct reports. Holds regular 1-on-1 meetings and Employee Development Plan discussions.
  • Accountable for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable.
  • Contributes to development of the department budget and tracks and controls expenses as needed to meet budget.
  • Exhibits our company Leadership Behaviors and provides a leadership example for the team.
  • Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
  • Maintains and provides expertise on External Quality systems, tools, data, and processes on an ongoing basis.
  • Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
  • May sponsor the interpretation and aggregation of financial/business data for External Quality Assurance and highlight concerns as appropriate to External Quality Assurance Management. Identifies and facilitates resolution of major deviations from financial or strategic plans. Coordinates the development, with the External Quality Assurance Senior staff, of the External Quality Assurance budget, Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
  • Accountable for oversight of an External Entity involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
  • Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight.  These components may include review of batch documentation and deviation investigations.
  • Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes building effective quality systems at the External Entity and continuous improvement activities.
  • Manages workload within team scope.
  • Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.

  • Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice.

Skills

REQUIRED: Education and Experience:

  • Education: Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
  • The Quality Lead, and Quality Authorized Person should at least have 5 years working experiences in pharmaceutical production and quality management, and at least 3 years working experiences in sterile manufacturing and quality management.
  • Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
  • Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
  • Communicates in English and Chinese, both verbally and in writing. 

Preferred Experience and Skills:

Prior management experience preferred.

Moderate level of contractual and financial awareness.

Previous experience participating in regulatory inspections.

Be conversant with all domestic and foreign regulations and compendia governing plant operations.

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. 

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:

No relocation

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

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