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Quality Compliance Manager

**Why Patients Need You** Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

**What You Will Achieve** The Rochester Manager/TL Compliance will be the site champion for Compliance Culture and will actively engage with the site leadership team and colleagues in strengthening the site compliance ownership. Responsible for ensuring that the sites Compliance standards, policies and procedures are aligned with global Pfizer Quality Standards and regulatory agency's guidance's and are operating in a state of control. Responsible for providing oversight of the following programs; Training, Supplier Management, Document Control, Inspection Readiness, Internal &Agency Audits / Inspections, Pfizer Quality Standards Assessments, Product Complaints, Annual Products Records Review (APRRs), Metrics, and is a member of Medical Device & Combination Products (MDCP) CAPA board. Additionally, will provide oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews, ensuring proper use of assets, budget and personnel. Communicates effectively with key customers and partners on and off site.

It is your managerial skills and hard work that will make Pfizer ready to achieve new milestones and help patients across the globe.

**How You Will Achieve It** Th i s pos i t i on l eads a team of i ndiv i dual contr i b u tor direct reports w i th a wide range of qual i ty responsibilities under the Medical Device-Combo Product regulations i ncludi ng:

+ S ite inspecti on readi ness

+ Internal Audit Program

+ Supplier Management

+ Training

+ Document Control

+ APRRs

+ Compla i nt management

+ Responses to audit observations

+ Facil i ty wa l k through's

+ Metrics reporting

Cand i date will be responsib l e for ens u r i ng i mpleme n tation and oversight of compl i ance at the Rochester site. This will require close collaboration with site and above site functional groups to ensure quality systems are understood and adhered to. Provide oversite/assistance of the Medical Device and Combination product program - conduct regulatory assessments, create/maintain design history file, participate and develop MDCP FMEAs, develop and report on key performance indicators (metrics), conduct internal audits, impact assess design changes, participate/coordinate CAPA Review Board (CRB).

Th i s pos i t i on will have responsibility for i nternal and external audit programs, s i te readiness for regulatory i nspect i ons, regu l atory comm i tments/responses. Wr i tes and de l i vers performance rev i ews. Provides oversight of department, ensuring proper use of assets, budget, and personnel. Communicates effecti vely with key customers and partners, both within the site and outside of it.

-Partner with site leadership and functional managers to develop a robust site strategy and action plan for improving compliance ownership at the site based on the results of the internal audit program results and assessments or as areas of opportunity are identified

-Ensure action plan items are completed on time and escalate risks to completion to the site leadership team, providing recommendations for mitigation as appropriate

-Facilitate a site-based communication mechanism and/or leverage an existing forum where colleagues participate in developing and sharing opportunities for the enhancement of a compliance ownership culture

-Partner with site DI Lead, OpEx /EHS Lead, QS/Sterility Assurance Lead, IMEx Lead, etc. to develop initiatives that promote continuous improvement in compliance with Pfizer policies and regulatory expectations and requirements.

Engaging, communicating, and influencing the site leadership team, as well as site colleagues, which is instrumental in achieving a compliance ownership culture which is aligned with Pfizer and regulatory expectations and requirements.

**Qualifications**

**Must-Have**

**Education:**

BS/MS or PhD In Chemistry, Biochemistry, Microbiology, Pharmacy or related science

**Experience:**

Minimum of 7 years of related experience in a cGMP environment, with a strong working knowledge of a variety of quality systems and processes including Drug, Medical Device, and Combination products. Pri or e xperience in a people management role strongly preferred. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. The candidate must have experience in at least several of the following: GMP (21 CFR parts 210, 211, 820), ISO 13485, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and batch record review.

**Communication:**

Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and i n a wide range of different work groups including senior leadership and regulatory agencies.

**Reasoning Ability:**

-Strong judgment, influencing skills and leadership abilities in working with different stakeholders

-Strong oral and written communication and organizational skills

-Demonstrated project management skills

-Ability to work well both independently and as part of a team, as well as cross functionally

-Self-motivated and energetic

-Ability to make decisions and solve problems

Technical Qualifications:

+ Understand regulatory requirements and audit strategy

+ Review and approve cGMP Documentation to assure compliance with regulatory requirements

+ Assess Deviation impacts and resolution

+ Review and approve cGMP Changes In accordance with regulatory requirements

+ Revi ew and approve training to assure cGMP requirements are met

+ Manage Resources meet organizational goals

+ Understand site financial systems

+ Understand Safety concerns and maintain safe environment (5S, ergonomics)

+ Ability to perform GAP assessments for new &; revised PQS

+ Ensure partic i pat i on i n company-wide knowledge exchanges

+ Review and approve all master documents pertaining to the manufacture, analysis, storage, and stability of cGMP products.

+ Abil i ty to thorough l y eva l uate qual i ty i nvestigat i on s , devia t ions, laboratory i nvest i gations, and follow- up actions are documented as they rel ate to the manufacturing, testing, distribution of raw material s, containers, closures, packing materi als, labeling, i n-process materi als, and final product.

+ Knowledge of all d rug products and med i cal dev i ces to assure comp l iance w i th app l i cable regu l atory requirements

Ability to provide oversight of the Medical Device and Combination product program - conduct regulatory assessments, create/maintain design history file, participate and develop MDCP FMEAs, develop and report on key performance indicators (metrics), conduct internal audits, impact assess design changes, participate/coordinate CAPA Review Board (CRB), and etc.

**Nice-to-Have**

+ Master's degree

+ Experience in aseptic manufacturing

**PHYSICAL/MENTAL REQUIREMENTS**

+ Must be able to lift a minimum of 30lbs

+ The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.

+ Committed to "Doing the right thing always"

+ Willing to embrace innovation and change in order to find solutions

+ Aware of the messaging needs of a diverse audience

+ Change agent

+ Willing to challenge the status quo

+ Fix it mentality rather than whose fault is it

+ Continuous improvement attitude

**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

+ Must not have a Penicillin allergy.

+ Minimal travel maybe required

**OTHER DETAILS**

+ **Last Date to Apply: April 19, 2021**

+ **Eligible for Relocation Package**

+ **Eligible for Employee Referral Bonus**

**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.

**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.

Quality Assurance and Control

\#LI-PFE

Quality Compliance Manager

Full time
Rochester, MI

Published on 04/08/2021

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