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Senior Manager MSQA


Peapack and Gladstone, NJ
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Job Details


Pfizer is committed to the delivery of safe and effective products to patients and consumers, a

Fundamental element of our Company's Purpose and Mission. To meet this commitment, Pfizer

maintains a quality-focused culture to ensure the highest priority is placed on the safety, efficacy

and reliability of our products, the safety of our patients and consumers, the quality of data supporting regulatory submissions, and interactions with our stakeholders.

The Senior Manager MSQA position is responsible for performing cGMP audits and assessments of Pfizer sites, contract vendors and select suppliers. The Senior Manager MSQA will assess programs, processes and procedures to assure compliance with policies and that the performance and quality of services conform to established standards and regulatory agency guidelines. This position leads audit and inspection preparation, resolution of audit and inspection findings and liaises with appropriate site and quality oversight teams through all stages of the audit. The Senior Manager MSQA develops and communicates complex ideas and may initiate and/or lead/co-lead cross functional complex projects. This position contributes to enabling a culture of excellence and to the continuous improvement of the company's quality management system through engagement with Pfizer site audit teams to incorporate audit lessons learned across the Network. Quality:


As assigned, independently conduct, participate and lead audits and assessments of contract manufacturers, select raw material suppliers and service providers, PGS sites that manufacture and distribute finished product and API, as well as Pfizer Country Office locations that have affiliate quality operations responsibility.

Assess adherence to relevant regulatory GMP guidance documents, Pfizer Quality Standards, Functional and local SOPs and Pfizer expectations.

+ Assess whether employees are being properly trained for their responsibilities

+ Assess continued adequacy of the facilities and equipment being used for manufacturing and testing of finished product and APIs

+ Assess the concepts of cGMPs and compliance with requirements in the quality agreement and/or with Pfizer expectations / standards.

+ Assess and report weaknesses that could lead to non-compliant manufacturing and/or distribution of products.

+ Assure that the facility / supplier / contract manufacturer is executing activities (manufacturing, testing, regulatory compliance) per Pfizer Quality agreements / expectations.

+ Communicate relevant quality, EHS and business information to the facility / supplier / contract manufacturer in an effort to maintain and enhance the relationship between the audited entity and Pfizer.

+ As assigned, aid the PGS site or applicable contract manufacturer in preparing for upcoming regulatory inspections

+ Applies technical knowledge to influence planning/designing cross functional projects

+ Interprets regulatory and business challenges and best practices to recommend improvements and/or solutions to cGMP or compliance issues at sites

Participate in Pfizer audits at the facility / supplier / contract manufacturer. Responsibilities for this activity include:

+ Assisting in scheduling the audit or schedule the audit.

+ Leading the audit, or actively participating in the audit as directed by the lead auditor.

+ Reviewing the audit report and assist in developing acceptable remediation plans.

+ Performing a follow-up as needed or as directed by PGS leadership

+ In appropriate situations, initiating reviews through consultation and agreement with others, including subject matter experts

Maintain the appropriate database with any relevant information pertaining to the facility / supplier / contract manufacturer audit.

Maintain and expand current knowledge of applicable laws, regulations, guidelines, and other pertinent policies, procedures, and standards that could impact the facility / supplier / contract manufacturer.

Liaise between the facility / supplier and the appropriate Pfizer group to ensure that any and all pertinent information is communicated such as any regulatory activity, any changes that are requested by Pfizer or the supplier or any pending or active regulation that may have an impact on the supplier's or Pfizer's business.

Conduct and participate in due diligence site assessments as required to determine compliance levels.

Able to collaborate proactively with leadership, sites and subject matter experts to enable a culture of excellence that is independent, fair audits as well as effective CAPAs. Additionally;

+ Can effectively cope with change during an audit

+ Able to lead a diverse audit team

+ Can relate to and has the ability to communicate and interact with all colleagues at every level ; anticipates potential objections and influences others to ensure appropriate outcomes

+ Knows how the business works by monitoring regulatory audit trends.

+ Has a diverse outlook to managing all kinds and classes of people.

+ Actively leads or participates in cross functional business significant complex projects and contributes towards outcomes that promote innovation and excellence


Bachelor's Degree, preferably in the natural sciences, or equivalent required.

Minimum 10 years progressive, challenging experience in pharmaceutical, biotech industry required (experience to include quality control / assurance, manufacturing, GMP auditing and may include product development) including:

+ Experienced in operational risk and compliance management, including experience in Quality auditing across a variety of dosage forms (e.g. analytical, API, biologics, aseptic, drug product, medical device) and "audit targets" (suppliers/contractors/facilities).

+ Must understand a variety of quality/operational systems that support contractor and supplier audits and quality supply chain management

+ Has a good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations and In-depth knowledge of cGMP regulations trends and expectations and familiar with other GXP concepts and global regulations (FDA, EU, TGA, PIC/S, etc.) and must be capable of understanding and reacting to business and regulatory trends

+ Understands GMP requirements (PQSs, local regulations, and regulations where the material / product is marketed), practical understanding of the facility operations and is able to communicate effectively in order to influence desired outcomes

+ Is qualified in three or more of the technical skill sets, preferably complex ones (analytical, API, biologics, aseptic, drug product, medical device) applicable to the facility audit. (Recognized Auditor certification preferred).

+ Critically evaluates information from the facility and the team and makes clear recommendations, and is able to propose potential solutions.

+ Must be adept at managing multiple tasks and changing assignment based on changing priorities. Is willing to proactively propose tasks as needed.

+ Good organizational skills (audit preparation, audit conduct, audit tracking) and issuance of audit reports aligned with MSQA audit metric targets.

+ Has the ability to recognize symptoms of problems or situations that require further evaluation, analyze symptoms to determine potential causes, suggest possible corrective actions. Can independently determine necessary input from subject matter experts in order to support these activities.

+ Ability to work independently and work well in a team as a lead auditor or participant, and an effective communicator to peers, Quality leaders and managers (inside and outside the company).

+ Actively works to achieve a balanced audit plan, supportive of urgent audit requests and flexible to changes.

+ Audit reports are written to reflect the required style and content, with findings levelled appropriately, and applying 'write right' and 'right first time' principals.

+ Ability to conduct ad hoc Quality assessments (e.g. Data Integrity, due diligence) as required to support business needs.

+ Ability to lead or participate in significant business related cross functional projects and contribute to innovative outcomes


Must be able to travel domestically and internationally.

Must be able to able to assess quality and compliance risks in the field and communicate potential regulatory and/or company non-compliance matters to senior leadership and/or third party vendor management and/or technical staff with assurance


Ability to travel globally between 40% (minimum) to 60% of time.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Other Job Details:**

+ **Last Date to Apply for Job: 3/6/2018**

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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