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Senior Manager COQA, Network Development and Integration


Zaventem, Vlaanderen 1930
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Job Details

The Sr. Manager in the COQA Network Development and Integration team provides Quality support to COQA, External Supply, PGS and key customers and stakeholders in the evaluation, selection, development, qualification and integration of new partners and contractors. The successful candidate is responsible for assuring commercial readiness of all new contractors / partners prior to commercial supply. This includes leading Quality due diligence assessments, qualifying new contractors and partners (including negotiating Quality Agreements), providing Quality support for new products (co-development teams), PNS initiatives (technical transfers / site divestitures), leading or participating in strategic COQA and GQO projects, and conducting third party assessments (Sterility Assurance, Quality Culture, Deviation, Packaging, etc.).

Activities include but are not limited to the following:

1. Leads and conducts Quality due diligence assessments of potential third parties in support of Business Development initiatives.

2. Works collaboratively with Global Quality Operations (GQO), Global Technology Services (GTS), and External Supply (ES) to ensure adherence to the GQO stage-gate process for the Evaluation and Selection of New Contractors and Partners by leading/supporting qualification and on-boarding activities.

3. Partners with Pharmaceutical Sciences and GTS to support co-development initiatives and new product launches ensuring commercial readiness of both contractor(s) and product(s).

4. Negotiates Quality Agreements for all new third parties.

5. Partners with GTS and ES to support technology transfers involving third parties managed or to be managed by COQA.

6. Participates in PGS site divestiture teams and provides Quality support to ensure appropriate integration of the divested site into the External Supply network.

7. Supports exit strategies of third parties under the oversight of COQA.

8. Provides support to the COQA operational teams by:

a. Ensuring a seamless transition into commercial and operational oversight of all new contractors;

b. Conducting third party assessments such as Sterility Assurance, Quality Culture, Deviation, Packaging, etc.;

c. Engaging, as needed, in significant issue resolution and remediation.

9. Leads strategic and Quality Risk Management initiatives to improve internal processes and reduce Quality risk of the COQA contractor network.

Organizational Relationships :

This position will report to the COQA Director/Team Leader, Network Development and Integration and will work collaboratively with COQA and External Supply leadership to support existing and new third parties. The successful candidate will also work across Global Quality Operations to align processes and provide Quality support and guidance in the selection and qualification of new third parties. This includes working with EMQO, IAQC, MSQA, and MAS. The position will also routinely interact with senior leadership of key stakeholders in Worldwide Business Development and the various Business Units.

Approximately 20% travel is expected.

Resources Managed :

The position has no direct reports.

1. A minimum of a Bachelor's degree in Microbiology, Chemistry, Pharmacy or related science, with a minimum of 10 years experience in the pharmaceutical industry including 5 years of relevant QA/QC/Mfg experience.

2. Experience in managing external suppliers is required.

3. Demonstrated ability to manage multiple projects and lead cross functional projects

4. Command of English language required and multi-lingual skills is beneficial. Comprehensive demonstrated written and verbal communication skills is required.

5. Demonstrated ability to negotiate and collaborate with individuals and groups at multiple levels across the organization including senior leadership of various functional lines across Pfizer Global Supply.

6. Demonstrated relationship building and negotiation skills, particularly in developing relationships with new customers and business partners.

7. Thorough knowledge of pharmaceutical cGMPs and global governmental regulations, including US FDA and EMA. Knowledge of consumer product regulations is desired.

8. Experience supporting or leading Quality audits and developing/managing remediation plans.

9. Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision.A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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