Manager, Qa Oversight To Engineering Operations & Investigation

Working with Us
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Position:Manager, QA Oversight to Engineering Operations & Investigations

Location: Manatí PR

Key Responsibilities

Supports the site inspection readiness state by: (a) conducting routine walkthroughs through operational areas, (b) observing practices vs procedures, (c) interacting with operational personnel, (d) examining selected manual, hybrid and/or electronic GMP documentation (e.g., Maximo), partnering with Engineering Operations to ensure that GMP procedures for processes owned/ lead by them are consistently followed.
Takes QA decisions by applying risk assessment/risk management principles to planned and unplanned events/ issues during operations (led by the Engineering function), using quality/ compliance knowledge and experience, using data, ensuring compliance to GMPs, BMS policies and guidelines.
Reviews/ approves Deviation Reports and Calibration Out of Tolerance events from QA standpoint, considering the nature (i.e., severity) of the issue, frequency and how it was detected, as well as compliance elements (e.g., if the deviation constitutes a departure from a validated state or regulatory filing; the impact of the issue).
Has active, early engagement in the deviation investigation process, before the write-up of the report, coaching personnel to ensure that a systematic approach is followed, using facts, data, technical inputs, quality/compliance considerations. Supports development of Impact Assessments and rationale for further processing, as needed.
Conducts thorough review of the outcome of deviation investigative work, developed as Investigation Reports, ensuring that the report (i) is standalone, following Technical Writing principles, (ii) shows a systematic Root Cause Analysis methodology, (iii) has the appropriate breadth -of potential root causes considered-, scope & depth (to get to true underlying root cause(s)), (iv) the report is well supported by facts, data, technical/ scientific rationale and (iv) the root cause connects well to the deviation, plus the CAPAs are aligned to the root cause.
Reviews and approves procedures or other types of GMP documents (e.g., reports, special protocols). The review must ensure that the documents are aligned to corporate standards, that families of procedures (of a related topic) are well connected (e.g., for Pest Control).
Provides QA inputs regarding responses to significant excursions in utilities, to rooms and storage conditions (e.g., differential pressures).
While reviewing GMP documents, ensures the adequacy and quality of outputs from processes, ensures they are feasible and aligned to cGMP/compliance expectations while being practical, driving forfrom his/herself and others.
Conducts data analysis, as needed to support deviation/investigations/change management/ technical evaluations, and/or other needs. Reviews and approves Corrective and Preventive actions (CAPA's) deliverables, ensuring they are appropriately to the deviation root cause(s) and deviation (i.e., the problem statement).
Provides key inputs and challenges proposed changes (for improvement, related to CAPAs, etc.) in partnership with the proponents, balancing the need to ensure quality/ compliance while adopting lean/ simplification principles. This may be in support of site projects, or other actions that are managed through the Change Control process and/or procedural change process.
Provides assistance to Engineering operational processes, when a new significant (GMP practice) change is being implemented, helping coach personnel on the GMP principles behind the change. Supports development of presentations/ materials to reinforce training of GMP topics and/or learnings from events.
Delivers periodic Quality Talks, in partnership with Engineering Operations management, to communicate to Engineering personnel what has been the outcome of key initiatives, deviations, investigations, changes, or emerging industry trends.
Supports site initiatives/projects, in addition to the product transfer initiatives and other assignments based on business needs.
During peaks of qualifications/ validations, supports the review and approval of related documentation.
Supports departmental budget preparation activities, in addition to budget adherence through time.
Identifies opportunities for continuous improvements and leads/ support through completion, as needed.
Manages audit observations, investigations, change control and CAPAs records in applicable QMS system.
Assists management during internal and regulatory agencies inspections.
This position acts and makes final decisions on matters related to:
Deviation determination and deviation report approval.
Deviation -Root Cause Analysis- Investigations review and approval.
Calibration Records (e.g., Out of Tolerance) from QA standpoint.
Standard Operating Procedures (SOPs) and other GMP procedures.
Continued operation upon detection of significant unplanned events/ deviations.
Notification to Management of significant issues/ matters.
The person in this role must feel comfortable taking decisions based on cGMPs, compliance, technical inputs from Subject Matter Experts (SME), while exercising risk management principles (considering severity, frequency, and detection mechanism of issues). The person needs to exercise judgement considering needs to escalate, based on facts & data).
The person in the role must be proactive, with an ability to work independently, as well as in teams; engaging SMEs as needed and recognizing the need to communicate across levels, as needed.

Qualifications & Experience

Bachelor's degree in engineering (preferred) or Science (e.g., Chemistry) with six (6) years of experience in a role exercising GMP responsibilities in a pharmaceutical industry. Three-five years of practical experience in Quality Systems (e.g., conducting and/or reviewing Investigations, CAPAs, Change Controls from the QA standpoint) in a GMP manufacturing environment. Knowledge of manufacturing operations of Parenteral Products Manufacturing. In depth knowledge of cGMPs, FDA, EU regulations and the ability to interpret and apply them for intended use. Demonstrable Skills needed in the following: Problem Solving, Critical Thinking, Learning Capability, Analytical Thinking, Strong Technical Writing Skills. Attention to details in review of GMP documents (e.g., in Investigation Reports, SOPs, CAPAs, Technical Reports) is required.
Individual must be able to identify what matters require to be dealt with sense of urgency; being able to work under fast-paced conditions and able to quickly identify when Subject Matter Experts and/or Senior Management must be involved. Individual should be a self-starter, with interpersonal skills and ability to interact with people at all levels. Fully bilingual (Spanish/English) with excellent communication skills, both written and verbal. Proficient knowledge of computer systems (Microsoft Office, etc.) and applications like Trackwise/Infinity.
Shifts: Able to work irregular hours, rotational shifts, 8 or 12 hrs shifts, weekends, and holidays, as needed.
Preferable background: Investigations review & approval experience under a Third Party (during Remediation), knowledge & in-depth experience on various GMP processes, e.g., Change Control, plus Lean/ Six Sigma training/ certifications, American Society for Quality certifications (e.g., CQE, CQM, CQA).

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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